Ruxolitinib Phosphate, Tacrolimus and Sirolimus in Preventing Acute Graft-versus-Host Disease During Reduced Intensity Donor Hematopoietic Cell Transplant in Patients With Myelofibrosis

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT02528877
Phase
PHASE1
Status
Withdrawn

Conditions

  • Acute Myeloid Leukemia in Remission
  • Primary Myelofibrosis
  • Primary Myelofibrosis, Prefibrotic Stage
  • Secondary Acute Myeloid Leukemia
  • Secondary Myelofibrosis

Eligibility Criteria

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

Interventions

  • Allogeneic Bone Marrow Transplantation — PROCEDURE
    Undergo allogeneic bone marrow transplant
  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic hematopoeitic stem cell transplant
  • Fludarabine Phosphate — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Melphalan — DRUG
    Given IV
  • Peripheral Blood Stem Cell Transplantation — PROCEDURE
    Undergo hematopoietic stem cell transplant
  • Pharmacological Study — OTHER
    Correlative studies
  • Ruxolitinib Phosphate — DRUG
    Given PO
  • Sirolimus — DRUG
    Given PO
  • Tacrolimus — DRUG
    Given IV or PO

Study Details

This phase I trial studies the side effects and best dose of ruxolitinib phosphate when given together with tacrolimus and sirolimus in preventing acute graft-versus-host disease during reduced intensity donor hematopoietic cell transplant in patients with myelofibrosis. Sometimes transplanted cells from a donor can attack the normal tissue of the transplant patient called graft-versus-host disease. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It may also reduce graft-versus-host disease by reducing inflammation and immune modulation. Giving ruxolitinib phosphate together with tacrolimus and sirolimus after transplant may prevent graft-versus-host disease.

Key Dates

Start date
Nov 30, 2015
Status verified
Sep 2016
Primary completion
Sep 30, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (ruxolitinib phosphate, tacrolimus, sirolimus)
    PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV on days -9 to -5 and melphalan IV over 20 minutes on day -4. Beginning greater than 48 hours after completion of melphalan, patients undergo peripheral blood stem cell or bone marrow transplant according to standard guidelines on day 0. GVHD PROPHYLAXIS: Patients receive ruxolitinib phosphate PO BID on days -3 to 30 tapered to day 60, tacrolimus IV continuously or PO BID on days -3 to 100 , and sirolimus PO QD on day -3 to 100. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events recorded using the modified Bearman scale and NCI CTCAE version 4.03 [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

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By research site
City of Hope Medical Center· Duarte, CA

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