Ruxolitinib Pre-, During- and Post-HSCT for Patients With Primary or Secondary Myelofibrosis.

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03427866
Phase
PHASE2
Status
Completed

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib is a medication that blocks certain proteins called tyrosine kinases. Specifically, it blocks tyrosine kinases called JAK2. The JAK2 pathway is over active in the disease, acute myeloid leukemia.

Study Details

This research study is studying a drug called Ruxolitinib as a possible treatment for Myelofibrosis.

Key Dates

Start date
Aug 28, 2018
Status verified
Jul 2025
Primary completion
May 1, 2024
Completion
May 19, 2025

Study Design

Enrollment
44 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib Eligible pre-HSCT
    * Ruxolitinib will be taken orally at a fixed dose twice every day * Dosing will be continuous, with a new cycle scheduled to start every 28 days. * There will be no break in dosing between cycles * Ruxolitinib can be administered with or without food.
  • Experimental: Ruxolitinib Not Eligible pre-HSCT
    * Ruxolitinib will be taken orally at a fixed dose twice every day after transplant * Dosing will be continuous, with a new cycle scheduled to start every 28 days. * There will be no break in dosing between cycles * Ruxolitinib can be administered with or without food.

Primary Outcome Measure

GVHD free and relapse free survival at 1 year [ Time Frame: 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02214-
Washington UniversitySt LouisMissouri63130-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Vanderbilt UniversityNashvilleTennessee37235-

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