Myelofibrosis  >>  Phase 3
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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Myelofibrosis
ACTRN12614000740695: Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis With Thrombocytopenia (PAC326)

Recruiting
3
300
 
Cell Therapeutics Inc., Cell Therapeutics Inc.
Primary Myelofibrosis
 
 
2011-001919-31: DALIAH A Danish Study of Low-dose Interferon Alpha Versus Hydroxyurea in the Treatment of Ph-negative Chronic Myeloid Neoplasias - A National Randomized Prospective Study With Focus on Efficacy, Toxicity and Quality of Life DALIAH Dansk Studie af Lav-dosis Interferon Alpha vs Hydroxyurea i Behandlingen af Ph-Negative kroniske myeloproliferative neoplasier “Et Nationalt Randomiseret Prospektivt Kvalitetssikringsstudie med Særlig Fokus på Effekt, Toxicitet og Livskvalitet”

Ongoing
3
200
Europe
Suspension for injection in pre-filled pen, Capsule, hard, Pegasys, PegIntron, Hydrea
Roskilde sygehus, Swedish Orphan, Ellen og Aage Fausbølls Helsefond af 1975, Fonden til lægevidenskabens Fremme, Odense Universitetshospitals forskningspulje, Region Sjællands og Region Syddanmarks fælles forskningspulje
Chronic myeloid neoplasms Essential thrombocythemia Polycythemia vera primary myelofibrosis Kroniske myeloide neoplasier Essential thrombocythemia Polycythemia vera primary myelofibrosis, Chronic myeloid neoplasms Essential thrombocythemia Polycythemia vera primary myelofibrosis Kroniske myeloide neoplasier Essential thrombocythemia Polycythemia vera primary myelofibrosis, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2012-004239-21: A study comparing current standard therapies with pacritinib taken by mouth for the treatment of myelofibrosis (either diagnosed alone or after polycythemia vera or essential thrombocytopenia)

Ongoing
3
75
Europe
pacritinib, SB1518,
CTI BioPharma Corp., CELL THERAPEUTICS INC., CTI BioPharma Corp., Cell Therapeutics Inc
Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
 
 
2013-004000-19: A study comparing current standard therapies with pacritinib taken by mouth for the treatment of myelofibrosis (either diagnosed alone or after polycythemia vera or essential thrombocytopenia) in patients with a low platelet count

Ongoing
3
50
Europe
pacritinib, SB1518,
CTI BioPharma Corp., Cell Therapeutics, Inc., CTI BioPharma Corp., Cell Therapeutics, Inc.
Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Thrombocytopenia
 
 
2020-000111-69: PACIFICA Phase 3: A Study of Pacritinib Versus Physician’s Choice in Patients with Myelofibrosis

Ongoing
3
348
Europe, RoW
Pacritinib, Ruxolitinib, Hydroxyurea, methylprednisolone, Dexamethasone, Prednisone, Capsule, hard, Tablet, Soluble tablet
CTI BioPharma Corp., CTI BioPharma Corp.
Primary Myelofibrosis, Post-essential thrombocythemia myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL), Post polycythaemia vera myelofibrosis, Primary or Secondary Myelofibrosis (MF), Diseases [C] - Cardiovascular Diseases [C14]
 
 
2020-003415-98: A phase 3 study of parsaclisib plus ruxolitinib in patients with myelofibrosis

Ongoing
3
212
Europe
parsaclisib, INCB050465, Tablet
Incyte Corporation, Incyte Corporation
myelofibrosis, myelofibrosis, Diseases [C] - Cancer [C04]
 
 
2020-003130-21: A phase 3 study of parsaclisib plus ruxolitinib in patients with myelofibrosis

Ongoing
3
440
Europe
parsaclisib, INCB050465, Tablet
Incyte Corporation, Incyte Corporation
myelofibrosis, myelofibrosis, Diseases [C] - Cancer [C04]
 
 
2020-004652-15: AVAJAK: Apixaban/rivaroxaban Versus Aspirin for primary prevention of thrombo-embolic complications in JAK2V617F-positive myelo-proliferative neoplasms AVAJAK: Apixaban/rivaroxaban Versus Aspirine en prévention primaire des complications thromboemboliques des néoplasies myéloprolifératives mutées pour JAK2V617F

Not yet recruiting
3
1340
Europe
Tablet, Gastro-resistant capsule, Eliquis, Xarelto, Aspirine Protec
CHRU de Brest, PHRC-K
Myelo-proliferative neoplasms including essential thrombocythemia, Polycythemia Vera, Prefibrotic myelofibrosis Néoplasies myéloprolifératives incluant les thrombocytémies essentielles, polyglobulies de Vaquez et pyélofibroses préfibrotiques, Myelo-proliferative neoplasms including essential thrombocythemia, Polycythemia Vera, Prefibrotic myelofibrosis Néoplasies myéloprolifératives incluant les thrombocytémies essentielles, polyglobulies de Vaquez et pyélofibroses préfibrotiques, Diseases [C] - Cancer [C04]
 
 
FREEDOM, NCT03755518: A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

Completed
3
38
Canada, US
FEDRATINIB
Celgene, Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
11/21
11/23
MOMENTUM, NCT04173494 / 2019-000583-18: A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants

Checkmark New data from MOMENTUM trial in myelofibrosis at ASH 2022
Dec 2022 - Dec 2022: New data from MOMENTUM trial in myelofibrosis at ASH 2022
Checkmark Results for symptomatic and anemic 2L Myelofibrosis based on MOMENTUM study at ASCO 2022
May 2022 - May 2022: Results for symptomatic and anemic 2L Myelofibrosis based on MOMENTUM study at ASCO 2022
Checkmark Data for myelofibrosis at ASCO 2022 based on from MOMENTUM trial
More
Completed
3
195
Europe, Canada, US, RoW
Momelotinib, MMB, GS-0387, CYT387, Placebo to match danazol, Danazol, Danocrine, Placebo to match momelotinib
Sierra Oncology LLC - a GSK company
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
12/21
12/22
FREEDOM2, NCT03952039 / 2018-003411-21: An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

Active, not recruiting
3
202
Europe, RoW
FEDRATINIB, Best Available Therapy (BAT)
Celgene, Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
12/22
06/25
NCT03480360: Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression

Active, not recruiting
3
21
US
Cyclophosphamide, Fludarabine, Total Body Irradiation, Tacrolimus, cellcept, g-csf, Peripheral Blood Transplant
Dartmouth-Hitchcock Medical Center
Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia, Myeloproliferative Disorder, Myelofibrosis, Lymphoma, Lymphoma, Non-Hodgkin, Plasma Cell Disorder
03/23
09/25
TRANSFORM-1, NCT04472598 / 2020-000097-15: Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis

Calendar Jan 2024 - Dec 2024: Approval for 1L myelofibrosis (based on TRANSFORM-1 trial)
Jan 2023 - Dec 2023: Data readout from TRANSFORM-1 trial in combination with Jakafi oral for myelofibrosis
Active, not recruiting
3
252
Europe, Canada, Japan, US, RoW
Navitoclax, ABT-263, Ruxolitinib, Placebo for Navitoclax
AbbVie
Myelofibrosis (MF)
04/23
01/25
ChiCTR2100046946: A Phase III, Randomized, Double-Blind Controlled Trial for Evaluating Jaktinib vs. Hydroxycarbamide in Subjects with Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis

Recruiting
3
105
 
Jaktinib hydrochloride tablets，100mg bid ;Hydroxycarbamide tablets 0.5g bid
The First Affiliated Hospital of Medical School of Zhejiang University; Suzhou Zelgen Biopharmaceuticals Co., Ltd, Suzhou Zelgen Biopharmaceuticals Co., Ltd.
Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post- essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
 
 
LIMBER-313, NCT04551066: To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

Active, not recruiting
3
252
Europe, Japan, US, RoW
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
08/23
07/24
LIMBER-304, NCT04551053: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib

Oct 2023 - Dec 2023: Data from LIMBER-304 trial n combination with ruxolitinib for myelofibrosis
Terminated
3
177
Europe, Japan, US, RoW
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
08/23
08/24
MANIFEST-2, NCT04603495 / 2020-001989-10: Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF)

Calendar Jan 2024 - Dec 2024: Approval for myelofibrosis
Jan 2024 - Mar 2024: From MANIFEST-2 trial in combination with ruxolitinib as a first-line treatment for patients with myelofibrosis
Feb 2024 - Feb 2024: Completion of P2b trial for JIA
Feb 2024 - Feb 2024: Exclusivity expiry in US
Active, not recruiting
3
430
Europe, Canada, US, RoW
Pelabresib, Ruxolitinib, Placebo
Constellation Pharmaceuticals
Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
08/23
12/27
NCT04816578: To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Recruiting
3
440
US
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
09/23
02/26
NCT04816565: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Not yet recruiting
3
212
Europe, US
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
11/23
12/23
ZGJAK016, NCT04617028: Jaktinib Versus Hydroxycarbamide in Subjects With Intermediate-2 or High-risk Myelofibrosis

Completed
3
105
RoW
Jaktinib, Placebo to match Hydroxycarbamide, Hydroxycarbamide Tablets, Placebo to match Jaktinib
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Myelofibrosis
10/23
10/23
ChiCTR2100047040: A Phase iii Study for Evaluating Jaktinib vs Hydroxycarbamide in Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis

Recruiting
3
105
 
Jaktinib, 100mg, bid ;Hydroxycarbamide, 0.5g，bid
The First Affiliated Hospital of Medical School of Zhejiang University; West China Hospital of Sichuan University, Suzhou Zelgen Biopharmaceuticals Co., Ltd.
Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post- essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
 
 
MK-3543-017, NCT06351631: A Study to Evaluate Safety and Efficacy of Bomedemstat

Recruiting
3
400
Europe, US, RoW
Bomedemstat, MK-3543, IMG-7289
Merck Sharp & Dohme LLC
Thrombocythemia, Essential, Primary Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera
12/34
12/34
POIESIS, NCT06479135: Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Recruiting
3
600
US
Navtemadlin, KRT-232, Navtemadlin placebo, Ruxolitinib, Jakafi, Jakavi
Kartos Therapeutics, Inc.
Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis, Primary Myelofibrosis, MF
12/26
12/28
TRANSFORM-2, NCT04468984 / 2020-000557-27: Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis

Calendar Jan 2024 - Dec 2024: Submission for r/r myelofibrosis in combination with Jakafi (based on TRANSFORM-2 trial)
Calendar Jan 2024 - Dec 2024: Data readout from TRANSFORM-2 trial in combination with ruxolitinib for r/r myelofibrosis
Active, not recruiting
3
295
Europe, Canada, Japan, US, RoW
Navitoclax, ABT-263, Ruxolitinib, Best Available Therapy (BAT)
AbbVie
Myelofibrosis (MF)
01/25
01/25
NCT06468033: P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

Not yet recruiting
3
150
NA
Ropeginterferon alfa-2b, P1101, Placebo
PharmaEssentia
Primary Myelofibrosis, Myeloproliferative Neoplasm
06/26
08/27
INDEPENDENCE, NCT04717414 / 2020-000607-36: An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

Calendar Jan 2025 - Dec 2025: Data from INDEPENDENCE trial for myelofibrosis
Active, not recruiting
3
309
Europe, Canada, Japan, US, RoW
ACE-536, Luspatercept, BMS-986346, Placebo
Celgene
Myeloproliferative Disorders, Myelofibrosis, Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Anemia
03/25
08/25
PACIFICA, NCT03165734 / 2017-001772-28: A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Calendar May 2026 - Sep 2026: Data from PACIFICA trial for myelofibrosis
Recruiting
3
399
Europe, Canada, US, RoW
Pacritinib, Physician's Choice medications, corticosteroids, hydroxyurea, danazol, low-dose ruxolitinib
CTI BioPharma, PSI CRO
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
06/25
12/25
SENTRY, NCT04562389: Study of Selinexor in Combination with Ruxolitinib in Myelofibrosis

Checkmark Presentation of data from Phase 1 trial for 1L Myelofibrosis at ASH 2022
Dec 2022 - Dec 2022: Presentation of data from Phase 1 trial for 1L Myelofibrosis at ASH 2022
Hourglass Dec 2022 - Dec 2022 : Data from trial in combination with ruxolitinib myelofibrosis
Checkmark Data from trial in combination with ruxolitinib myelofibrosis at ASH 2022
Dec 2022 - Dec 2022: Data from trial in combination with ruxolitinib myelofibrosis at ASH 2022
More
Recruiting
3
330
Europe, Canada, US, RoW
Selinexor, KPT-330, Placebo, Ruxolitinib
Karyopharm Therapeutics Inc
Myelofibrosis
09/25
03/28
IMpactMF, NCT04576156 / 2020-003288-24: A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment

Calendar Jan 2025 - Dec 2025: Final analysis data from IMpactMF trial for refractory myelofibrosis
Calendar Jan 2024 - Dec 2024: Interim analysis data from IMpactMF trial for refractory myelofibrosis
Checkmark Trial updates from IMpactMF trial for relapsed/refractory myelofibrosis at ASH 2022
Dec 2022 - Dec 2022: Trial updates from IMpactMF trial for relapsed/refractory myelofibrosis at ASH 2022
Recruiting
3
320
Europe, US, RoW
Imetelstat, GRN163L, Best Available Therapy (BAT)
Geron Corporation
Myelofibrosis
11/26
11/26
AVAJAK, NCT05198960: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms

Recruiting
3
1308
Europe
Direct Oral Anticoagulants, Low-dose aspirin
University Hospital, Brest
Polycythemia Vera, Essential Thrombocythemia, Prefibrotic/Early Primary Myelofibrosis, JAK2 V617F, High-risk Patients
07/27
07/27
LTFU, NCT04064060 / 2018-002915-93: A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Recruiting
3
665
Europe, Canada, Japan, US, RoW
Luspatercept, ACE-536
Celgene
Myelodysplastic Syndromes (MDS), Beta-thalassemia, Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis
05/28
05/28
BOREAS, NCT03662126 / 2018-001671-21: KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment

Recruiting
2/3
385
Europe, Canada, US, RoW
KRT-232, Best Available Therapy (BAT)
Kartos Therapeutics, Inc., Kartos Therapeutics, Inc.
Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Post-Essential Thrombocythemia MF (Post-ET-MF)
12/23
12/25

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