JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT02251821
Phase
PHASE2
Status
Completed

Conditions

  • Primary Myelofibrosis
  • Secondary Myelofibrosis

Eligibility Criteria

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

Interventions

  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic hematopoietic stem cell transplant
  • Busulfan — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine Phosphate — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Melphalan — DRUG
    Given IV
  • Methotrexate — DRUG
    Given IV
  • Mycophenolate Mofetil — DRUG
    Given IV or PO
  • Ruxolitinib — DRUG
    Given PO
  • Tacrolimus — DRUG
    Given IV or PO
  • Total-Body Irradiation — RADIATION
    Undergo TBI
  • Umbilical Cord Blood Transplantation — PROCEDURE
    Undergo umbilical cord blood transplant

Study Details

This phase II trial studies how well giving a JAK inhibitor before a donor stem cell transplant works in treating patients with myelofibrosis that developed without another condition (primary) or evolved from other bone marrow disorders (secondary). JAK inhibitors are a class of drugs that may stop the growth of abnormal cells by blocking an enzyme needed for cell growth. Giving a JAK inhibitor such as ruxolitinib before a donor stem cell transplant may help reduce symptoms of myelofibrosis such as inflammation and enlargement of the spleen, improve the patient's general physical condition, and prevent complications from occurring after the transplant. Infusing healthy stem cells from a donor into the patient may help the patient's bone marrow work normally and make stem cells, red blood cells, white blood cells, and platelets. Giving a JAK inhibitor before a donor stem cell transplant may help improve transplant outcomes in patients with myelofibrosis.

Key Dates

Start date
Oct 20, 2014
Status verified
Jan 2026
Primary completion
Dec 28, 2022
Completion
Jan 22, 2026

Study Design

Enrollment
61 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ruxolitinib, transplant)
    Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.

Primary Outcome Measure

2-year Overall Survival (OS) in Patients With Myelofibrosis (MF) Who Receive Treatment With a JAK Inhibitor Followed by an Allogeneic Transplant [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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