CURRENT CLINICAL TRIALS FOR THE MPNs
Source of all information: clinicaltrials.gov

· Trials for Myelofibrosis

· Trials for Polcythemia Vera

· Trials for Essential Thrombocythemia

· Trials for other MPNs


1. Trials for Myelofibrosis
Line No. Recruiting Status Condition(s) to be Studied Drugs tested and primary outcomes clinicaltrials.gov ref. # - click it for more information Study title Study Phase*
1 Recruiting Myeloproliferative Neoplasms Drug: Pomalidomide
Objective disease response, as defined by the IWG-MRT criteria for response in MF patients extended by the criterion RBC-transfusion independence (TI)
NCT00949364 Pomalidomide in Patients With Myeloproliferative Neoplasms in Fibrotic Stage Phase II
2 Recruiting Myeloproliferative Diseases Drug: Ruxolitinib

Drug: Lenalidomide

Drug: Prednisone
Objective Response Rate
Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT).
NCT01375140 Ruxolitinib and Lenalidomide for Patients With Myelofibrosis Phase II
3 Recruiting Myeloproliferative Disorders

Thrombocythemia, Essential

Polycythemia Vera

Primary Myelofibrosis
Drug: LY2784544
  • Determination of a recommended Phase 2 dosing regimen
  • Number of participants with clinical significant effects
NCT01134120 A Study in Myeloproliferative Disorders Phase I
4 Recruiting Thrombocythemia

Myeloproliferative Disorder
Drug: Hydroxyurea

Drug: Aspirin
  • Does hydroxyurea reduce thrombosis and major haemorrhage when added to aspirin?
  • What is the effect of the treatment modalities on quality of life?
NCT00175838 Primary Thrombocythaemia 1 Trial _
5 Recruiting AML

CML

MDS

Myeloproliferative Disorders
Drug: STA-9090 (ganetespib)
  • To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies
  • To assess preliminary evidence of anti-neoplastic activity
  • To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion
NCT00858572 STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders Phase I

Phase II
6 Recruiting Primary Myelofibrosis Drug: Pomalidomide

Other: Placebo
Proportion of subjects achieving RBC-transfusion-independence
NCT01178281 Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence Phase III
8 Recruiting Myeloproliferative Disorders

Hematologic Neoplasms

Myelodysplastic Syndromes
Procedure: Total Lymphoid Irradiation (TLI)

Procedure: Anti-Thymocyte Globulin as Conditioning
  • To improve survival outcome for selected patients with advanced stages of MDS and MPD with non-myeloablative allogeneic HCT from related and unrelated donors.
  • To evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly patients or those with co-morbid conditions that preclude myeloablative transplantation for advanced stage MDS and MPD.
NCT00185796 TLI & ATG for Non-Myeloablative Allogeneic Transplantation for MDS and MPD Phase II
10 Not yet recruiting Polycythemia Vera

Essential Thrombocythemia

Primary Myelofibrosis
Drug: PegIntron

Drug: Pegasys

Drug: Hydrea

Drug: Multiferon
molecular response (changes from baseline)
Molecular responses (JAK V617F allele burden) are assesed by qPCR according to the ELN guidelines.
NCT01387763 A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms Phase III
11 Recruiting Polycythemia Vera Drug: INC424 tablets

Other: Best Available Therapy (BAT)
Proportion of subjects achieving a response at Week 32. 'Response' is defined as having achieved both: (1) the absence of protocol-defined phlebotomy eligibility and (2) a ≥ 35% reduction from baseline in spleen volume as determined by imaging
NCT01243944 Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: The RESPONSE Trial Phase III
12 Recruiting High Risk Polycythemia Vera

High Risk Essential Thrombocythemia
Drug: PEGASYS

Drug: Hydroxyurea

Drug: Aspirin
To compare hematologic response rates in patients randomized to treatment with Pegylated Interferon Alfa-2a vs Hydroxyurea in two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET).
NCT01259856 Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Phase III
13 Recruiting Myelofibrosis Drug: Busulfan

Drug: Fludarabine

Drug: Thymoglobulin (ATG)
Rate of Non-Relapse Mortality (NRM)
NCT00475020 Allogeneic Stem Cell Transplantation for Myelofibrosis Phase II
14 Recruiting Hematopoietic Neoplasm Drug: SAR302503

Drug: Placebo
Response Rate (RR), defined as the proportion of patients who have a ≥35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter
NCT01437787 Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis Phase III
15 Not yet recruiting High Risk Polycythemia Vera

High Risk Essential Thrombocythemia
Drug: PEGASYS

Drug: Aspirin
Evaluate the ability of Pegylated Interferon Alfa-2a to achieve Complete Response or Partial Response in patients with (1) high risk polycythemia vera or (2) high risk essential thrombocythemia or (3) splanchnic vein thrombosis
NCT01259817 Pegylated Interferon Alfa-2a Salvage Therapy in High Risk Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Phase II
16 Recruiting Thrombocythemia, Hemorrhagic Drug: Anagrelide

Drug: Hydroxyurea
Cardiovascular safety as assessed by echocardiography over 3 years.
NCT00202644 A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients Phase IV
17 Recruiting Essential Thrombocythaemia Drug: Anagrelide retard

Drug: Placebo
Time to 1st clinically significant ET related event
NCT01230775 Anagrelide Retard vs. Placebo: Efficacy and Safety in "At-risk" Patients With Essential Thrombocythaemia Phase III
18 Recruiting Myelodysplastic Syndrome (MDS)

Aplastic Anaemia (AA)

Myelofibrosis (MF)

Thalassemia Intermedia
Drug: Chinese herbal concoction twice a day for 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability

The following parameters will be monitored serially

  1. symptoms : ie reflection of any subjective symptoms that may be due to the treatment
  2. Serial biochemistry ( urea, electrolyte, creatinine, liver function test ) will be done at baseline, one week into the study and then every 7-8 weekly till end of the 6 months. This will monitor for any organ toxicity
NCT01224496 Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders Phase I

Phase II
19 Not yet recruiting Primary Myelofibrosis

Post-Essential Thrombocythemia Myelofibrosis
Drug: AB0024
Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment.
If no patients respond after 2 cycles, the study will be stopped.
NCT01242709 Study in Patients With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis Phase II
20 Recruiting Myelofibrosis Drug: GS-6624 (AB0024) at 700 mg

Drug: GS-6624 (AB0024) at 200 mg
Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment
•To evaluate the efficacy of AB0024 as therapy for Primary Myelofibrosis (PMF) and Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (post-PV MF or post-ET MF). Best overall response will be categorized according to the International Working Group (IWG) Criteria. Efficacy will be measured by Rate of clinical response as defined by IWG criteria. Stable disease with improvement in bone marrow fibrosis score, clinical improvement, partial remission, or complete remission will be considered a response.
NCT01369498 A Phase 2 Study to Evaluate the Efficacy and Safety of AB0024 in Adults With Myelofibrosis Phase II
21 Recruiting Polycythemia Vera

Thrombocythemia
Drug: CC-4047
Number of Patients with Response
NCT00946270 Pomalidomide for Myelofibrosis Patients Phase II
22 Recruiting Polycythemia Vera Drug: PEG-P-INF alpha-2b (P1101)
Maximum tolerated dose (MTD)
The definition of MTD is based on a 3+3 dose escalation design. MTD is defined as the next lower dose of that dose which was considered to be untolerated (observed DLT frequency at least 2 out of 3 in one cohort or at least 2 out of six patients in 2 cohorts).
NCT01193699 Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera Phase I

Phase II
23 Recruiting Essential Thrombocythaemia Drug: SPD422 (anagrelide hydrochloride)
Safety of long-term use of SPD422
Safety will be determined by the changes from study baseline in clinical laboratory evaluations, vital signs, and electrocardiograms (ECGs) recorded as an AE if clinically relevant.
NCT01467661 Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia Phase III
25 Recruiting Primary Myelofibrosis Drug: Dose Escalating Arsenic Trioxide plus ascorbic Acid
To determine the safety and maximum tolerated dose of oral arsenic trioxide with or without ascorbic acid is subjects with JAK2-positive myelofibrosis
NCT01014546 Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With Myelofibrosis Phase I
26 Recruiting Myelofibrosis

Primary Myelofibrosis

Post-polycythemia Vera Related Myelofibrosis

Post-essential Thrombocythemia Related Myelofibrosis
Biological: monoclonal antibody to TGF-beta
To assess the safety and tolerability of GC1008 in patients with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF).
NCT01291784 Anti-TGF-beta Therapy in Patients With Myelofibrosis Phase I
27 Recruiting Primary Myelofibrosis

Fibrosis, Bone Marrow
Drug: oral daily dosing
To determine the overall response rate of IPI-926, defined as clinical improvement (CI); partial remission (PR); and complete remission (CR), according to the International working group (IWG) criteria in patients with Myelofibrosis
NCT01371617 A Phase 2 Study With IPI-926 in Patients With Myelofibrosis Phase II
28 Recruiting Hematopoietic Neoplasm Drug: SAR302503
The percent change in spleen volume based on MRI at the end of Cycle 3 relative to baseline
NCT01420770 Phase 2 Study of SAR302503 in Patients With Myelofibrosis Phase II
29 Recruiting Hematopoietic Neoplasm Drug: SAR302503
  • Polycythemia vera: Proportion of patients with absence of phlebotomy and hematocrit below 45% for a minimum of 3 months after completion of 8 cycles of therapy
  • Essential thrombocythemia: Proportion of patients with a platelet count ≤ 400 x 10x9/L for a minimum of 3 months after completion of 8 cycles of therapy
NCT01420783 Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia Phase II
30 Available Myelofibrosis

Post Polycythemia Myelofibrosis

Post-essential Thrombocythemia Myelofibrosis
Drug: INC424
 
NCT01493414 INC424 for Patients With Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis Expanded Access
31 Recruiting Primary Myelofibrosis (MF)

Post-Polycythemia Vera (PV) MF

Post-Essential Thrombocythemia (ET) MF
Drug: Ruxolitinib
Efficacy by reduction in spleen volume
NCT01392443 Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF Phase II
33 Recruiting Myelodysplastic Syndromes Drug: Group 2: Placebo

Drug: Group 1: Epoetin alfa
Erythroid response
NCT01381809 An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes Phase III
34 Recruiting Primary Myelofibrosis

Post-Polycythemia Vera Related Myelofibrosis

Post-Essential Thrombocythemia Related Myelofibrosis
Drug: LBH589
  • To assess the safety and tolerability of oral LBH589 in patients with PMF, post-PV/ET MF
    Phase I
  • Evaluation of treatment response by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)
    Phase II
NCT01298934 LBH589 (Panobinostat) for the Treatment of Myelofibrosis Phase I

Phase II
35 Recruiting Idiopathic Myelofibrosis

Post Essential Thrombocythemia Myelofibrosis

Post Polycythemia-Vera Myelofibrosis
Drug: panobinostat, ruxolitinib
Percentage of Responders as measured by a change in spleen length of at least 50% reduction as determined by manual palpation; from Baseline (Cycle 1 Day 1) to Week 12, and maintained until Week 24
NCT01433445 Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis Phase I
36 Recruiting Polycythemia Vera Drug: Erlotinib
Overall response rate to include Complete Hematological response, Complete molecular response, partial hematological response, and minimal hematological response
NCT01038856 Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera Phase II
37 Recruiting Primary Myelofibrosis

Post-Polycythemia Vera

Post-Essential Thrombocythemia Myelofibrosis
Drug: CYT387
  • To determine the safety of CYT387 by characterization and relationship of adverse events, affects on vital signs and laboratory parameters, and QTc intervals as measured by electrocardiogram (ECG)
  • To determine maximum tolerated dose of CYT387 by characterization of Dose Limiting Toxicities
  • To confirm the half-life of CYT387 by pharmacokinetic analyses
  • To determine the efficacy of CYT387 by evaluation of spleen and liver size, disease related constitutional symptoms, transfusion dependence and anemia response.
NCT01423058 Safety Study Evaluating Twice-Daily Administration of CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis Phase I

Phase II
38 Recruiting Primary Myelofibrosis

Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
Drug: Ruxolitinib
Mean % change in spleen volume as measured by MRI
NCT01445769 Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis Phase II
39 Recruiting Myelofibrosis Drug: Ruxolitinib
To establish the MSSD of ruxolitinib in patients with MF and baseline platelet counts < 100,000 as measured through blood sampling.
NCT01317875 Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) Phase I
40 Recruiting Primary Myelofibrosis

Post Essential Thrombocythemia-myelofibrosis

Post Polycythemia Vera-myelofibrosis
Drug: Ruxolitinib (INCB018424)
Measure spleen volume changes in patients with PMF, PPV-MF and PET-MF
NCT01348490 Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis Phase II
* Brief explanation of Study Phases:
  • Phase I trials study safety and side effects.
  • Phase II trials study effectiveness and safety.
  • Phase III trials further study effectiveness and side effects, and compare with existing treatments.
  • Phase IV trials study a treatment after it has entered the market.

Phases I, II and III involve progressively larger groups of people.

For further explanation, see clinicaltrials.gov.

[ Back To Top ]

2. Trials for Polcythemia Vera
Line No. Recruiting Status Condition(s) to be Studied Drugs tested and primary outcomes clinicaltrials.gov ref. # - click it for more information Study title Study Phase*
1 Recruiting High Risk Polycythemia Vera

High Risk Essential Thrombocythemia
Drug: PEGASYS

Drug: Hydroxyurea

Drug: Aspirin
To compare hematologic response rates in patients randomized to treatment with Pegylated Interferon Alfa-2a vs Hydroxyurea in two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET).
NCT01259856 Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Phase III
2 Recruiting Polycythemia Vera Drug: INC424 tablets

Other: Best Available Therapy (BAT)
Proportion of subjects achieving a response at Week 32. 'Response' is defined as having achieved both: (1) the absence of protocol-defined phlebotomy eligibility and (2) a ≥ 35% reduction from baseline in spleen volume as determined by imaging
NCT01243944 Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: The RESPONSE Trial Phase III
3 Not yet recruiting High Risk Polycythemia Vera

High Risk Essential Thrombocythemia
Drug: PEGASYS

Drug: Aspirin
Evaluate the ability of Pegylated Interferon Alfa-2a to achieve Complete Response or Partial Response in patients with (1) high risk polycythemia vera or (2) high risk essential thrombocythemia or (3) splanchnic vein thrombosis
NCT01259817 Pegylated Interferon Alfa-2a Salvage Therapy in High Risk Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Phase II
4 Not yet recruiting Polycythemia Vera

Essential Thrombocythemia

Primary Myelofibrosis
Drug: PegIntron

Drug: Pegasys

Drug: Hydrea

Drug: Multiferon
molecular response (changes from baseline)
Molecular responses (JAK V617F allele burden) are assesed by qPCR according to the ELN guidelines.
NCT01387763 A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms Phase III
5 Recruiting Polycythemia Vera Drug: PEG-P-INF alpha-2b (P1101)
Maximum tolerated dose (MTD)
The definition of MTD is based on a 3+3 dose escalation design. MTD is defined as the next lower dose of that dose which was considered to be untolerated (observed DLT frequency at least 2 out of 3 in one cohort or at least 2 out of six patients in 2 cohorts).
NCT01193699 Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera Phase I

Phase II
6 Recruiting Polycythemia Vera

Thrombocythemia
Drug: CC-4047
Number of Patients with Response
NCT00946270 Pomalidomide for Myelofibrosis Patients Phase II
7 Recruiting Myelofibrosis

Primary Myelofibrosis

Post-polycythemia Vera Related Myelofibrosis

Post-essential Thrombocythemia Related Myelofibrosis
Biological: monoclonal antibody to TGF-beta
To assess the safety and tolerability of GC1008 in patients with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF).
NCT01291784 Anti-TGF-beta Therapy in Patients With Myelofibrosis Phase I
8 Recruiting Primary Myelofibrosis (MF)

Post-Polycythemia Vera (PV) MF

Post-Essential Thrombocythemia (ET) MF
Drug: Ruxolitinib
Efficacy by reduction in spleen volume
NCT01392443 Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF Phase II
9 Recruiting Myeloproliferative Disorders

Thrombocythemia, Essential

Polycythemia Vera

Primary Myelofibrosis
Drug: LY2784544
  • Determination of a recommended Phase 2 dosing regimen
  • Number of participants with clinical significant effects
NCT01134120 A Study in Myeloproliferative Disorders Phase I
10 Not yet recruiting Primary Myelofibrosis

Post-Essential Thrombocythemia Myelofibrosis
Drug: AB0024
Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment.
If no patients respond after 2 cycles, the study will be stopped.
NCT01242709 Study in Patients With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis Phase II
11 Recruiting Polycythemia Vera Drug: Erlotinib
Overall response rate to include Complete Hematological response, Complete molecular response, partial hematological response, and minimal hematological response
NCT01038856 Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera Phase II
12 Recruiting Primary Myelofibrosis

Post-Polycythemia Vera

Post-Essential Thrombocythemia Myelofibrosis
Drug: CYT387
  • To determine the safety of CYT387 by characterization and relationship of adverse events, affects on vital signs and laboratory parameters, and QTc intervals as measured by electrocardiogram (ECG)
  • To determine maximum tolerated dose of CYT387 by characterization of Dose Limiting Toxicities
  • To confirm the half-life of CYT387 by pharmacokinetic analyses
  • To determine the efficacy of CYT387 by evaluation of spleen and liver size, disease related constitutional symptoms, transfusion dependence and anemia response.
NCT01423058 Safety Study Evaluating Twice-Daily Administration of CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis Phase I

Phase II
13 Recruiting Primary Myelofibrosis

Post Essential Thrombocythemia-myelofibrosis

Post Polycythemia Vera-myelofibrosis
Drug: Ruxolitinib (INCB018424)
Measure spleen volume changes in patients with PMF, PPV-MF and PET-MF
NCT01348490 Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis Phase II
14 Recruiting Idiopathic Myelofibrosis

Post Essential Thrombocythemia Myelofibrosis

Post Polycythemia-Vera Myelofibrosis
Drug: panobinostat, ruxolitinib
Percentage of Responders as measured by a change in spleen length of at least 50% reduction as determined by manual palpation; from Baseline (Cycle 1 Day 1) to Week 12, and maintained until Week 24
NCT01433445 Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis Phase I
15 Recruiting Primary Myelofibrosis

Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
Drug: Ruxolitinib
Mean % change in spleen volume as measured by MRI
NCT01445769 Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis Phase II
16 Recruiting Hematopoietic Neoplasm Drug: SAR302503
  • Polycythemia vera: Proportion of patients with absence of phlebotomy and hematocrit below 45% for a minimum of 3 months after completion of 8 cycles of therapy
  • Essential thrombocythemia: Proportion of patients with a platelet count ≤ 400 x 10x9/L for a minimum of 3 months after completion of 8 cycles of therapy
NCT01420783 Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia Phase II
17 Recruiting Primary Myelofibrosis

Post-Polycythemia Vera Related Myelofibrosis

Post-Essential Thrombocythemia Related Myelofibrosis
Drug: LBH589
  • To assess the safety and tolerability of oral LBH589 in patients with PMF, post-PV/ET MF
    Phase I
  • Evaluation of treatment response by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)
    Phase II
NCT01298934 LBH589 (Panobinostat) for the Treatment of Myelofibrosis Phase I

Phase II
18 Recruiting Hematopoietic Neoplasm Drug: SAR302503

Drug: Placebo
Response Rate (RR), defined as the proportion of patients who have a ≥35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter
NCT01437787 Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis Phase III
20 Recruiting Myelofibrosis Drug: GS-6624 (AB0024) at 700 mg

Drug: GS-6624 (AB0024) at 200 mg
Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment
•To evaluate the efficacy of AB0024 as therapy for Primary Myelofibrosis (PMF) and Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (post-PV MF or post-ET MF). Best overall response will be categorized according to the International Working Group (IWG) Criteria. Efficacy will be measured by Rate of clinical response as defined by IWG criteria. Stable disease with improvement in bone marrow fibrosis score, clinical improvement, partial remission, or complete remission will be considered a response.
NCT01369498 A Phase 2 Study to Evaluate the Efficacy and Safety of AB0024 in Adults With Myelofibrosis Phase II
21 Recruiting Hematopoietic Neoplasm Drug: SAR302503
The percent change in spleen volume based on MRI at the end of Cycle 3 relative to baseline
NCT01420770 Phase 2 Study of SAR302503 in Patients With Myelofibrosis Phase II
22 Recruiting Myelofibrosis Drug: Ruxolitinib
To establish the MSSD of ruxolitinib in patients with MF and baseline platelet counts < 100,000 as measured through blood sampling.
NCT01317875 Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) Phase I
23 Recruiting Myelofibrosis Drug: Busulfan

Drug: Fludarabine

Drug: Thymoglobulin (ATG)
Rate of Non-Relapse Mortality (NRM)
NCT00475020 Allogeneic Stem Cell Transplantation for Myelofibrosis Phase II
24 Recruiting Myeloproliferative Diseases Drug: Ruxolitinib

Drug: Lenalidomide

Drug: Prednisone
Objective Response Rate
Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT).
NCT01375140 Ruxolitinib and Lenalidomide for Patients With Myelofibrosis Phase II
25 Recruiting Primary Myelofibrosis Drug: Pomalidomide

Other: Placebo
Proportion of subjects achieving RBC-transfusion-independence
NCT01178281 Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence Phase III
* Brief explanation of Study Phases:
  • Phase I trials study safety and side effects.
  • Phase II trials study effectiveness and safety.
  • Phase III trials further study effectiveness and side effects, and compare with existing treatments.
  • Phase IV trials study a treatment after it has entered the market.

Phases I, II and III involve progressively larger groups of people.

For further explanation, see clinicaltrials.gov.

[ Back To Top ]

3. Trials for Essential Thrombocythemia
Line No. Recruiting Status Condition(s) to be Studied Drugs tested and primary outcomes clinicaltrials.gov ref. # - click it for more information Study title Study Phase*
1 Recruiting High Risk Polycythemia Vera

High Risk Essential Thrombocythemia
Drug: PEGASYS

Drug: Hydroxyurea

Drug: Aspirin
To compare hematologic response rates in patients randomized to treatment with Pegylated Interferon Alfa-2a vs Hydroxyurea in two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET).
NCT01259856 Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Phase III
2 Not yet recruiting High Risk Polycythemia Vera

High Risk Essential Thrombocythemia
Drug: PEGASYS

Drug: Aspirin
Evaluate the ability of Pegylated Interferon Alfa-2a to achieve Complete Response or Partial Response in patients with (1) high risk polycythemia vera or (2) high risk essential thrombocythemia or (3) splanchnic vein thrombosis
NCT01259817 Pegylated Interferon Alfa-2a Salvage Therapy in High Risk Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Phase II
3 Recruiting Essential Thrombocythaemia Drug: Anagrelide retard

Drug: Placebo
Time to 1st clinically significant ET related event
NCT01230775 Anagrelide Retard vs. Placebo: Efficacy and Safety in "At-risk" Patients With Essential Thrombocythaemia Phase III
4 Not yet recruiting Primary Myelofibrosis

Post-Essential Thrombocythemia Myelofibrosis
Drug: AB0024
Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment.
If no patients respond after 2 cycles, the study will be stopped.
NCT01242709 Study in Patients With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis Phase II
5 Recruiting Essential Thrombocythaemia Drug: SPD422 (anagrelide hydrochloride)
Safety of long-term use of SPD422
Safety will be determined by the changes from study baseline in clinical laboratory evaluations, vital signs, and electrocardiograms (ECGs) recorded as an AE if clinically relevant.
NCT01467661 Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia Phase III
6 Available Myelofibrosis

Post Polycythemia Myelofibrosis

Post-essential Thrombocythemia Myelofibrosis
Drug: INC424
 
NCT01493414 INC424 for Patients With Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis Expanded Access
7 Not yet recruiting Polycythemia Vera

Essential Thrombocythemia

Primary Myelofibrosis
Drug: PegIntron

Drug: Pegasys

Drug: Hydrea

Drug: Multiferon
molecular response (changes from baseline)
Molecular responses (JAK V617F allele burden) are assesed by qPCR according to the ELN guidelines.
NCT01387763 A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms Phase III
8 Recruiting Myelofibrosis

Primary Myelofibrosis

Post-polycythemia Vera Related Myelofibrosis

Post-essential Thrombocythemia Related Myelofibrosis
Biological: monoclonal antibody to TGF-beta
To assess the safety and tolerability of GC1008 in patients with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF).
NCT01291784 Anti-TGF-beta Therapy in Patients With Myelofibrosis Phase I
10 Recruiting Primary Myelofibrosis (MF)

Post-Polycythemia Vera (PV) MF

Post-Essential Thrombocythemia (ET) MF
Drug: Ruxolitinib
Efficacy by reduction in spleen volume
NCT01392443 Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF Phase II
11 Recruiting Primary Myelofibrosis

Post-Polycythemia Vera

Post-Essential Thrombocythemia Myelofibrosis
Drug: CYT387
  • To determine the safety of CYT387 by characterization and relationship of adverse events, affects on vital signs and laboratory parameters, and QTc intervals as measured by electrocardiogram (ECG)
  • To determine maximum tolerated dose of CYT387 by characterization of Dose Limiting Toxicities
  • To confirm the half-life of CYT387 by pharmacokinetic analyses
  • To determine the efficacy of CYT387 by evaluation of spleen and liver size, disease related constitutional symptoms, transfusion dependence and anemia response.
NCT01423058 Safety Study Evaluating Twice-Daily Administration of CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis Phase I

Phase II
12 Recruiting Idiopathic Myelofibrosis

Post Essential Thrombocythemia Myelofibrosis

Post Polycythemia-Vera Myelofibrosis
Drug: panobinostat, ruxolitinib
Percentage of Responders as measured by a change in spleen length of at least 50% reduction as determined by manual palpation; from Baseline (Cycle 1 Day 1) to Week 12, and maintained until Week 24
NCT01433445 Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis Phase I
13 Recruiting Primary Myelofibrosis

Post Essential Thrombocythemia-myelofibrosis

Post Polycythemia Vera-myelofibrosis
Drug: Ruxolitinib (INCB018424)
Measure spleen volume changes in patients with PMF, PPV-MF and PET-MF
NCT01348490 Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis Phase II
14 Recruiting Thrombocythemia

Myeloproliferative Disorder
Drug: Hydroxyurea

Drug: Aspirin
  • Does hydroxyurea reduce thrombosis and major haemorrhage when added to aspirin?
  • What is the effect of the treatment modalities on quality of life?
NCT00175838 Primary Thrombocythaemia 1 Trial _
15 Recruiting Thrombocythemia, Hemorrhagic Drug: Anagrelide

Drug: Hydroxyurea
Cardiovascular safety as assessed by echocardiography over 3 years.
NCT00202644 A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients Phase IV
16 Recruiting Primary Myelofibrosis

Post-Polycythemia Vera Related Myelofibrosis

Post-Essential Thrombocythemia Related Myelofibrosis
Drug: LBH589
  • To assess the safety and tolerability of oral LBH589 in patients with PMF, post-PV/ET MF
    Phase I
  • Evaluation of treatment response by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)
    Phase II
NCT01298934 LBH589 (Panobinostat) for the Treatment of Myelofibrosis Phase I

Phase II
17 Recruiting Hematopoietic Neoplasm Drug: SAR302503
  • Polycythemia vera: Proportion of patients with absence of phlebotomy and hematocrit below 45% for a minimum of 3 months after completion of 8 cycles of therapy
  • Essential thrombocythemia: Proportion of patients with a platelet count ≤ 400 x 10x9/L for a minimum of 3 months after completion of 8 cycles of therapy
NCT01420783 Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia Phase II
18 Recruiting Polycythemia Vera

Thrombocythemia
Drug: CC-4047
Number of Patients with Response
NCT00946270 Pomalidomide for Myelofibrosis Patients Phase II
19 Recruiting Primary Myelofibrosis

Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
Drug: Ruxolitinib
Mean % change in spleen volume as measured by MRI
NCT01445769 Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis Phase II
20 Recruiting Hematopoietic Neoplasm Drug: SAR302503

Drug: Placebo
Response Rate (RR), defined as the proportion of patients who have a ≥35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter
NCT01437787 Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis Phase III
21 Recruiting Myelofibrosis Drug: GS-6624 (AB0024) at 700 mg

Drug: GS-6624 (AB0024) at 200 mg
Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment
•To evaluate the efficacy of AB0024 as therapy for Primary Myelofibrosis (PMF) and Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (post-PV MF or post-ET MF). Best overall response will be categorized according to the International Working Group (IWG) Criteria. Efficacy will be measured by Rate of clinical response as defined by IWG criteria. Stable disease with improvement in bone marrow fibrosis score, clinical improvement, partial remission, or complete remission will be considered a response.
NCT01369498 A Phase 2 Study to Evaluate the Efficacy and Safety of AB0024 in Adults With Myelofibrosis Phase II
23 Recruiting Hematopoietic Neoplasm Drug: SAR302503
The percent change in spleen volume based on MRI at the end of Cycle 3 relative to baseline
NCT01420770 Phase 2 Study of SAR302503 in Patients With Myelofibrosis Phase II
24 Recruiting Myelofibrosis Drug: Ruxolitinib
To establish the MSSD of ruxolitinib in patients with MF and baseline platelet counts < 100,000 as measured through blood sampling.
NCT01317875 Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) Phase I
25 Recruiting Myelofibrosis Drug: Busulfan

Drug: Fludarabine

Drug: Thymoglobulin (ATG)
Rate of Non-Relapse Mortality (NRM)
NCT00475020 Allogeneic Stem Cell Transplantation for Myelofibrosis Phase II
26 Recruiting Myeloproliferative Diseases Drug: Ruxolitinib

Drug: Lenalidomide

Drug: Prednisone
Objective Response Rate
Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT).
NCT01375140 Ruxolitinib and Lenalidomide for Patients With Myelofibrosis Phase II
27 Recruiting Primary Myelofibrosis Drug: Pomalidomide

Other: Placebo
Proportion of subjects achieving RBC-transfusion-independence
NCT01178281 Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence Phase III
28 Recruiting Primary Myelofibrosis

Fibrosis, Bone Marrow
Drug: oral daily dosing
To determine the overall response rate of IPI-926, defined as clinical improvement (CI); partial remission (PR); and complete remission (CR), according to the International working group (IWG) criteria in patients with Myelofibrosis
NCT01371617 A Phase 2 Study With IPI-926 in Patients With Myelofibrosis Phase II
29 Recruiting Myeloproliferative Disorders

Thrombocythemia, Essential

Polycythemia Vera

Primary Myelofibrosis
Drug: LY2784544
  • Determination of a recommended Phase 2 dosing regimen
  • Number of participants with clinical significant effects
NCT01134120 A Study in Myeloproliferative Disorders Phase I
* Brief explanation of Study Phases:
  • Phase I trials study safety and side effects.
  • Phase II trials study effectiveness and safety.
  • Phase III trials further study effectiveness and side effects, and compare with existing treatments.
  • Phase IV trials study a treatment after it has entered the market.

Phases I, II and III involve progressively larger groups of people.

For further explanation, see clinicaltrials.gov.

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4. Trials for other MPNs
Line No. Recruiting Status Condition(s) to be Studied Drugs tested and primary outcomes clinicaltrials.gov ref. # - click it for more information Study title Study Phase*
1 Recruiting Myelofibrosis Drug: Busulfan

Drug: Fludarabine

Drug: Thymoglobulin (ATG)
Rate of Non-Relapse Mortality (NRM)
NCT00475020 Allogeneic Stem Cell Transplantation for Myelofibrosis Phase II
2 Recruiting Primary Myelofibrosis Drug: Pomalidomide

Other: Placebo
Proportion of subjects achieving RBC-transfusion-independence
NCT01178281 Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence Phase III
3 Not yet recruiting Primary Myelofibrosis

Post-Essential Thrombocythemia Myelofibrosis
Drug: AB0024
Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment.
If no patients respond after 2 cycles, the study will be stopped.
NCT01242709 Study in Patients With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis Phase II
4 Recruiting Myelofibrosis

Primary Myelofibrosis

Post-polycythemia Vera Related Myelofibrosis

Post-essential Thrombocythemia Related Myelofibrosis
Biological: monoclonal antibody to TGF-beta
To assess the safety and tolerability of GC1008 in patients with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF).
NCT01291784 Anti-TGF-beta Therapy in Patients With Myelofibrosis Phase I
5 Not yet recruiting Polycythemia Vera

Essential Thrombocythemia

Primary Myelofibrosis
Drug: PegIntron

Drug: Pegasys

Drug: Hydrea

Drug: Multiferon
molecular response (changes from baseline)
Molecular responses (JAK V617F allele burden) are assesed by qPCR according to the ELN guidelines.
NCT01387763 A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms Phase III
6 Available Myelofibrosis

Post Polycythemia Myelofibrosis

Post-essential Thrombocythemia Myelofibrosis
Drug: INC424
 
NCT01493414 INC424 for Patients With Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis Expanded Access
7 Recruiting Myelofibrosis Drug: GS-6624 (AB0024) at 700 mg

Drug: GS-6624 (AB0024) at 200 mg
Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment
•To evaluate the efficacy of AB0024 as therapy for Primary Myelofibrosis (PMF) and Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (post-PV MF or post-ET MF). Best overall response will be categorized according to the International Working Group (IWG) Criteria. Efficacy will be measured by Rate of clinical response as defined by IWG criteria. Stable disease with improvement in bone marrow fibrosis score, clinical improvement, partial remission, or complete remission will be considered a response.
NCT01369498 A Phase 2 Study to Evaluate the Efficacy and Safety of AB0024 in Adults With Myelofibrosis Phase II
8 Recruiting Primary Myelofibrosis Drug: Dose Escalating Arsenic Trioxide plus ascorbic Acid
To determine the safety and maximum tolerated dose of oral arsenic trioxide with or without ascorbic acid is subjects with JAK2-positive myelofibrosis
NCT01014546 Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With Myelofibrosis Phase I
9 Recruiting Primary Myelofibrosis

Fibrosis, Bone Marrow
Drug: oral daily dosing
To determine the overall response rate of IPI-926, defined as clinical improvement (CI); partial remission (PR); and complete remission (CR), according to the International working group (IWG) criteria in patients with Myelofibrosis
NCT01371617 A Phase 2 Study With IPI-926 in Patients With Myelofibrosis Phase II
10 Recruiting Primary Myelofibrosis (MF)

Post-Polycythemia Vera (PV) MF

Post-Essential Thrombocythemia (ET) MF
Drug: Ruxolitinib
Efficacy by reduction in spleen volume
NCT01392443 Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF Phase II
11 Recruiting Myeloproliferative Diseases Drug: Ruxolitinib

Drug: Lenalidomide

Drug: Prednisone
Objective Response Rate
Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT).
NCT01375140 Ruxolitinib and Lenalidomide for Patients With Myelofibrosis Phase II
12 Recruiting Hematopoietic Neoplasm Drug: SAR302503

Drug: Placebo
Response Rate (RR), defined as the proportion of patients who have a ≥35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter
NCT01437787 Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis Phase III
13 Recruiting Primary Myelofibrosis

Post Essential Thrombocythemia-myelofibrosis

Post Polycythemia Vera-myelofibrosis
Drug: Ruxolitinib (INCB018424)
Measure spleen volume changes in patients with PMF, PPV-MF and PET-MF
NCT01348490 Ruxolitinib (INCB018424) in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis Phase II
14 Recruiting Idiopathic Myelofibrosis

Post Essential Thrombocythemia Myelofibrosis

Post Polycythemia-Vera Myelofibrosis
Drug: panobinostat, ruxolitinib
Percentage of Responders as measured by a change in spleen length of at least 50% reduction as determined by manual palpation; from Baseline (Cycle 1 Day 1) to Week 12, and maintained until Week 24
NCT01433445 Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis Phase I
15 Recruiting Primary Myelofibrosis

Post-Polycythemia Vera Related Myelofibrosis

Post-Essential Thrombocythemia Related Myelofibrosis
Drug: LBH589
  • To assess the safety and tolerability of oral LBH589 in patients with PMF, post-PV/ET MF
    Phase I
  • Evaluation of treatment response by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)
    Phase II
NCT01298934 LBH589 (Panobinostat) for the Treatment of Myelofibrosis Phase I

Phase II
16 Recruiting Primary Myelofibrosis

Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
Drug: Ruxolitinib
Mean % change in spleen volume as measured by MRI
NCT01445769 Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis Phase II
17 Recruiting Primary Myelofibrosis

Post-Polycythemia Vera

Post-Essential Thrombocythemia Myelofibrosis
Drug: CYT387
  • To determine the safety of CYT387 by characterization and relationship of adverse events, affects on vital signs and laboratory parameters, and QTc intervals as measured by electrocardiogram (ECG)
  • To determine maximum tolerated dose of CYT387 by characterization of Dose Limiting Toxicities
  • To confirm the half-life of CYT387 by pharmacokinetic analyses
  • To determine the efficacy of CYT387 by evaluation of spleen and liver size, disease related constitutional symptoms, transfusion dependence and anemia response.
NCT01423058 Safety Study Evaluating Twice-Daily Administration of CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis Phase I

Phase II
18 Recruiting Myeloproliferative Disorders

Thrombocythemia, Essential

Polycythemia Vera

Primary Myelofibrosis
Drug: LY2784544
  • Determination of a recommended Phase 2 dosing regimen
  • Number of participants with clinical significant effects
NCT01134120 A Study in Myeloproliferative Disorders Phase I
19 Recruiting Myelodysplastic Syndrome (MDS)

Aplastic Anaemia (AA)

Myelofibrosis (MF)

Thalassemia Intermedia
Drug: Chinese herbal concoction twice a day for 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability

The following parameters will be monitored serially

  1. symptoms : ie reflection of any subjective symptoms that may be due to the treatment
  2. Serial biochemistry ( urea, electrolyte, creatinine, liver function test ) will be done at baseline, one week into the study and then every 7-8 weekly till end of the 6 months. This will monitor for any organ toxicity
NCT01224496 Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders Phase I

Phase II
20 Recruiting Polycythemia Vera

Thrombocythemia
Drug: CC-4047
Number of Patients with Response
NCT00946270 Pomalidomide for Myelofibrosis Patients Phase II
21 Recruiting Hematopoietic Neoplasm Drug: SAR302503
The percent change in spleen volume based on MRI at the end of Cycle 3 relative to baseline
NCT01420770 Phase 2 Study of SAR302503 in Patients With Myelofibrosis Phase II
22 Recruiting Myelofibrosis Drug: Ruxolitinib
To establish the MSSD of ruxolitinib in patients with MF and baseline platelet counts < 100,000 as measured through blood sampling.
NCT01317875 Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) Phase I
24 Recruiting Cancer Drug: BMS-911543
  • Safety assessed by medical review of adverse events and results of vital signs, Electrocardiograms (ECGs), physical examinations, and lab tests and evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
  • Total number of subjects with the Investigator reported Complete Remission (CR), Partial remission (PR), or Clinical improvement (CI) divided by the total number of treated subjects
NCT01236352 Multiple Ascending Dose of BMS-911543 Phase I

Phase II
* Brief explanation of Study Phases:
  • Phase I trials study safety and side effects.
  • Phase II trials study effectiveness and safety.
  • Phase III trials further study effectiveness and side effects, and compare with existing treatments.
  • Phase IV trials study a treatment after it has entered the market.

Phases I, II and III involve progressively larger groups of people.

For further explanation, see clinicaltrials.gov.

[ Back To Top ]

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