Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Jonathan Brammer
Study ID
NCT07356245
Phase
PHASE2
Status
Recruiting

Conditions

  • Adult T-cell Leukemia/Lymphoma
  • Cutaneous T Cell Lymphoma
  • Graft Versus Host Disease
  • Lymphoma, T-Cell
  • Peripheral T Cell Lymphoma
  • Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • T-cell Lymphoma
  • T-cell Prolymphocytic Leukemia

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Administered orally twice daily
  • Positron emission tomography-computed tomography — PROCEDURE
    Undergo PET-CT Scan
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The "graft" is the donor blood cells that patients get during the transplant. The "host" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.

Key Dates

Start date
Feb 12, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ruxolitinib maintenance)
    Starting day +35 to day +120 post-SCT, patients receive ruxolitinib PO BID on days 1-30 of each cycle. Cycles repeat every 30 days for 1 year post-SCT, in the absence of disease progression or unacceptable toxicity. Patients undergo PET-CT scan and blood sample collection throughout the study. Patients may undergo bone marrow biopsy and/or tissue biopsy throughout the study, at time of progression.

Primary Outcome Measure

Cumulative Incidence (CI) of relapse [ Time Frame: at 1-year post-auto-SCT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Jonathan Brammer, MD
Jonathan Brammer, MD (PRINCIPAL_INVESTIGATOR)

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