Ruxolitinib for T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jonathan Brammer, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Adults with T-cell lymphoma in partial/complete remission post-stem cell transplant can join. They must be fairly active (ECOG ≤2), have stable blood counts without recent transfusions, normal organ function, and agree to use birth control. Ineligible if they can't take oral meds or sign consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ruxolitinib orally twice daily starting day +35 to day +120 post-SCT, with cycles repeating every 30 days for 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 18 and 24 months, then yearly until 5 years and at progression
What Are the Treatments Tested in This Trial?
Interventions
- Ruxolitinib
Trial Overview
The trial is testing Ruxolitinib as a maintenance drug to prevent relapse and GVHD after stem cell transplantation for T-cell lymphoma. It's a phase II study assessing the effectiveness of this JAK inhibitor in reducing immune response and cancer growth.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonathan Brammer
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
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