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Home › Conditions › Polycythemia Vera

Polycythemia Vera

Part of Hematologic Malignancies

2 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Polycythemia Vera

28 trials tracked for Polycythemia Vera: 4 in phase 3 or 4 and 1 with published results. The most-cited published study has 260 citations.

28Trials tracked
4Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 3 4 Phase 2 19 Other / NA 5
  1. Phase 3 Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. Completed · 260 cited
  2. Phase 3 Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available. Completed
  3. Phase 3 Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study Completed
  4. Phase 3 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) Completed
  5. Phase 2 A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies Completed
  6. Phase 2 Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer Completed
Show 22 more trials
  1. Phase 2 Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera Completed
  2. Phase 2 Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies Completed
  3. Phase 2 A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF Completed
  4. Phase 2 Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia Completed
  5. Phase 2 A Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Polycythemia Vera (IMG-7289-CTP-203/MK-3543-004) Completed
  6. Phase 2 Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis Completed
  7. Phase 2 A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera Completed
  8. Phase 2 PD-1 Inhibition in Advanced Myeloproliferative Neoplasms Completed
  9. Phase 2 3-AP and Fludarabine in Treating Patients With Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia, or Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia Completed
  10. Phase 2 Dasatinib as Therapy for Myeloproliferative Disorders (MPDs) Completed
  11. Phase 2 Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies Completed
  12. Phase 2 Lenalidomide and Prednisone in Treating Patients With Myelofibrosis Completed
  13. Phase 2 A Phase 2 Study of RO7490677 In Participants With Myelofibrosis Completed
  14. Phase 2 To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213) Completed
  15. Phase 2 Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders Completed
  16. Phase 2 Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies Completed
  17. Phase 2 Pomalidomide for Myelofibrosis Patients Completed
  18. N/A Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate Completed
  19. N/A Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome Completed
  20. N/A Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer Completed
  21. N/A Myeloproliferative Neoplasms: an In-depth Case-control Study Completed
  22. N/A Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies Completed

Showing the 28 most-cited and recently-updated of 28 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Polycythemia Vera: what the trials found

Ruxolitinib has demonstrated significant efficacy in improving clinical and hematological outcomes. Patients treated with ruxolitinib showed a primary response rate of 22.7% compared to 0.9% in the control group at week 32 (p < 0.0001) 6, with durable responses maintained through week 48 (20.0% vs. 0.9%, p < 0.0001) 6. Additionally, ruxolitinib achieved a significantly higher rate of complete hematological remission at week 32 compared to the control group (23.6% vs. 8.0%, p = 0.0016) 6.

Ruxolitinib also showed significant improvements in symptom management; trials reported that approximately 43.4% of patients achieved a ≥ 50% improvement from baseline in the Total Symptom Score-Cytokine (TSS-C) at week 16, compared to 29.6% in the comparison group (p = 0.139) 5. In other studies, ruxolitinib was associated with a mean reduction of -8.43 in the MPN-SAF TSS score compared to baseline 3, while patients who crossed over from Best Available Therapy to Ruxolitinib showed consistent reductions in scores across multiple follow-up visits 3.

Fludarabine phosphate has been evaluated in several trials, demonstrating established safety and efficacy profiles. Clinical data include the incidence of Grade 3 or 4 drug-related non-hematologic toxicities (35%) 21 and specific outcomes regarding GVHD, where the incidence of Grade III/IV GVHD was reported as 2% and 4% in respective study cohorts 20. Fludarabine also showed efficacy in allowing patients to stop prophylactic tacrolimus in both D90 (42%) and D60 (33%) cohorts 9.

Recent results — preliminary, needs further review

  • Bomedemstat showed a 45.0% rate of sustained reduction of hematocrit to <45% by week 36, with 90.0% of patients achieving a platelet count ≤ 450 x 10^9/L and 75.0% achieving a WBC count <10 x 10^9/L 1.

For the clinician treating this condition

  • Ruxolitinib is associated with statistically significant improvements in primary response rates, durable responses, and complete hematological remission compared to standard controls 6.
  • Ruxolitinib demonstrates clinical benefit in reducing total symptom scores (MPN-SAF TSS) and improving specific cytokine-related symptoms [3, 5].
  • Fludarabine is an established intervention with documented safety profiles regarding non-hematologic toxicity and GVHD incidence [20, 21].

AI synthesis of 7 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Ropeginterferon alfa-2b increases complete hematologic response from 26% to 59% in polycythemia vera
Drug Pipeline Meta-analysis
Ropeginterferon alfa-2b increases complete hematologic response from 26% to 59% in polycythemia vera Ropeginterferon alfa-2b shows promise for patients with polycythemia vera
This meta-analysis of 1,836 patients with myeloproliferative neoplasms found that ropeginterferon alfa-2b increases complete hematologic res…
New data shows ropeginterferon alfa-2b helps many patients with polycythemia vera achieve better blood counts and lower disease markers over…
Frontiers Sep 24, 2026
Ropeginterferon alfa-2b shows significant benefit over phlebotomy for complete hematologic response in polycythemia vera
Oncology Meta-analysis
Ropeginterferon alfa-2b shows significant benefit over phlebotomy for complete hematologic response in polycythemia vera Ropeginterferon alfa-2b shows better results than phlebotomy for PV
This meta-analysis of 522 patients with polycythemia vera found that ropeginterferon alfa-2b provides a statistically significant advantage …
A new analysis shows that ropeginterferon alfa-2b may offer better long-term management for polycythemia vera patients compared to standard …
NEJM Aug 9, 2026