Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT04384692
Phase
PHASE2
Status
Active Not Recruiting

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 HSCT
  • Busulfan — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine — DRUG
    Given IV
  • Melphalan — DRUG
    Given IV
  • Methotrexate — DRUG
    Given IV
  • Mycophenolate Mofetil — DRUG
    Given IV or PO
  • Ruxolitinib — DRUG
    Given PO
  • Tacrolimus — DRUG
    Given IV and PO
  • Total-Body Irradiation — RADIATION
    Undergo TBI
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Echocardiography — PROCEDURE
    Undergo echocardiography
  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Ultrasound Imaging — PROCEDURE
    Undergo ultrasound imaging

Study Details

This phase II trial studies how well administering ruxolitinib before, during, and after allogeneic hematopoietic stem cell transplantation works in preventing graft versus host disease and improving transplant outcomes in patients with primary and secondary myelofibrosis. Donor hematopoietic stem cell transplantation (HSCT) is currently the only treatment with proven curative potential for myelofibrosis, however, myelofibrosis patients have a high risk for developing graft versus host disease post-transplant. Graft versus host disease is a condition where the transplanted cells from a donor can attack the body's normal cells. Ruxolitinib, a janus-associated kinase (JAK) inhibitor, is known to decrease inflammatory signals, which may reduce spleen size and decrease symptoms such as night sweats and weight loss. Administering ruxolitinib before, during, and after transplant may decrease the incidence and severity of graft versus host disease, increase survival, and improve quality of life in patients with primary and secondary myelofibrosis.

Key Dates

Start date
Dec 18, 2020
Status verified
Apr 2026
Primary completion
Apr 3, 2026
Completion
Apr 23, 2030

Study Design

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

Arms

  • Experimental: Treatment (ruxolitinib, conditioning, HSCT, GVHD prophylaxis)
    See detailed description.

Primary Outcome Measure

Incidence of grade II-IV graft versus host disease (GVHD) in myelofibrosis patients [ Time Frame: Up to day 100 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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

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