Ruxolitinib in Thrombocythemia and Polycythemia Vera

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04644211
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Essential Thrombocythemia
  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This research is being done to see if the drug ruxolitinib is effective in reducing the symptoms caused by low-risk essential thrombocythemia (ET) and polycythemia vera (PV). \- This research study involves the study drug Ruxolitinib.

Key Dates

Start date
Mar 21, 2022
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2034

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib Stage 1
    In stage 1, participants will be divided into two cohorts: * Very low, Low, and Intermediate-risk ETpatients with significant symptom burden and Low-risk PV patients with significant symptom burden * Study cycles are 28 days long, participants in both cohorts will receive: * Ruxolitinib 2x daily for 6 study cycles.
  • Experimental: Ruxolitinib Stage 2
    Stage 2 will commence based on 3 or more participants in Stage 1 showing a predetermined positive response to Ruxolitinib. In stage 2, participants will be divided into two cohorts: * Very low, Low, and Intermediate-risk ET patients with significant symptom burden and Low-risk PV patients with significant symptom burden * Study cycles are 28 days long, participants in both cohorts will receive: * Ruxolitinib 2x daily for 6 study cycles.

Primary Outcome Measure

Percentage of patients who achieve >50% reduction from baseline to Myeloproliferative Neoplasm Symptom Assessment Total Symptom Score [ Time Frame: baseline to 12 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Beth-Israel Deaconess Medical CenterBostonMassachusetts02215
Jeffrey Zwicker, MD
[email protected]
(617) 667-9920
Jeffrey Zwicker, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Marlise Luskin, MD
[email protected]
(617) 632-1906
Marlise Luskin, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02115
Gabriela Hobbs, MD
[email protected]
(617) 726-8748
Gabriela Hobbs, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General North Shore Cancer CenterDanversMassachusetts01923
Michelle H. Lee, MD
[email protected]

Find similar trials in Boston, MA

By research site
Beth-Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAMassachusetts General North Shore Cancer Center· Danvers, MA

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