Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult Patients With Acquired Aplastic Anemia

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT06752694
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Bone Marrow Transplantation — PROCEDURE
    Undergo bone marrow transplant
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Cyclosporine — DRUG
    Given PO
  • Fludarabine — DRUG
    Given IV
  • Granulocyte Colony-Stimulating Factor — DRUG
    Given SC
  • Mycophenolate Mofetil — DRUG
    Given PO
  • Peripheral Blood Stem Cell Transplantation — PROCEDURE
    Undergo PBSC transplantation
  • Ruxolitinib — DRUG
    Given PO
  • Sirolimus — DRUG
    Given PO
  • Total-Body Irradiation — RADIATION
    Undergo TBI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Echocardiography — PROCEDURE
    Undergo ECHO

Study Details

This phase II trial tests how well a ruxolitinib-based graft versus host disease (GVHD) prevention (prophylaxis) regimen works before, during, and after bone marrow/stem cell transplantation (hematopoietic cell transplantation \[HCT\]) in patients with acquired aplastic anemia. Acquired aplastic anemia (AA) is a condition in which the bone marrow is unable to produce blood cells. Affected patients typically present with infections due to abnormally low number of neutrophils, bleeding due to low platelet count, and/or fatigue due to a lower-than-normal number of red blood cells (anemia). Its incidence varies with age, occurring most frequently in patients aged 2-5 years, 20-25 years, and 55 years and older. Treatment of AA includes either immunosuppressive therapy (IST) or bone marrow/stem cell transplantation (HCT) with first-line therapy in younger adults often being HCT, while adults over 40 still frequently trial IST first due to the morbidity and mortality concerns with HCT. GVHD is a common complication after donor stem cell transplantation, resulting from donor immune cells recognizing recipients' cells and attacking them. Ruxolitinib, a drug in a class of oral medications called JAK inhibitors has been approved for the treatment of acute and chronic GVHD. It has also been shown to decrease GVHD when used in the prevention setting in patients with myelofibrosis. The current study aims to assess whether adding ruxolitinib to a standard GVHD prevention regimen may reduce the risk of Grade II-IV acute and chronic GVHD after bone marrow/stem cell transplantation in older patients with acquired aplastic anemia.

Key Dates

Start date
Sep 25, 2025
Status verified
May 2026
Primary completion
Jan 23, 2026
Completion
Oct 15, 2026

Study Design

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

Arms

  • Experimental: Prevention (conditioning, transplant, GVHD prophylaxis)
    See Detailed Description.

Primary Outcome Measure

Incidence of grades II-IV acute graft-versus-host disease (GVHD) [ Time Frame: At day 100 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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

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