Study on Ruxolitinib Maintenance After Stem Cell Transplant for T-Cell Lymphoma

Sponsor: Jonathan Brammer

Sponsor score: 0

ClinicalTrials ID:NCT07356245

Provider View

This clinical trial is exploring whether the drug ruxolitinib can help prevent relapse and graft-versus-host disease (GVHD) in patients who have undergone stem cell transplants for T-cell lymphoma. GVHD is a condition where the donor's cells attack the recipient's body. Ruxolitinib may help by reducing the immune response and blocking cancer cell growth.

Patient Parameters

Program Overview

This study is testing if ruxolitinib, a medication taken after a stem cell transplant, can help prevent the return of T-cell lymphoma and reduce the risk of graft-versus-host disease (GVHD). GVHD happens when the donor's cells attack the patient's body after a transplant. Ruxolitinib works by calming the immune system and stopping cancer cells from growing. The study will see if taking ruxolitinib for a year after the transplant can help patients stay cancer-free and avoid GVHD.

Description

The main goals of this study are to see if ruxolitinib can prevent the return of T-cell lymphoma and reduce the risk of graft-versus-host disease (GVHD) one year after a stem cell transplant. The study will also look at how safe and feasible it is to use ruxolitinib as a maintenance treatment after the transplant.

Participants will start taking ruxolitinib between 35 and 120 days after their transplant. They will take the medication twice a day for 30 days at a time, repeating this cycle for up to a year, as long as there are no serious side effects or disease progression. Throughout the study, participants will have regular scans and blood tests, and may have biopsies if needed.

After finishing the treatment, participants will have follow-up visits at 18 and 24 months, and then yearly until five years, or if the disease progresses.

Eligibility Criteria

Inclusion Criteria

  • Adults with T-cell lymphoma in partial or complete remission 35 to 120 days after a stem cell transplant.
  • Good overall health with a performance status of 2 or less.
  • Adequate blood cell counts and organ function, including:
    • Neutrophil count over 1000/mm3 without recent growth factor support.
    • Platelet count over 50,000/mm3 without recent transfusion.
    • Hemoglobin over 8.0 g/dL without recent transfusion.
    • Normal liver and kidney function, and good heart and lung function.
  • Able to take oral medications.
  • Agree to use effective birth control during the study.
  • Able to read and sign informed consent.

Exclusion Criteria

  • Certain types of lymphoma with low risk of relapse in first remission.
  • Disease progression or need for other systemic therapy after transplant.
  • Previous progression on ruxolitinib.
  • GVHD requiring systemic treatment.
  • Active, uncontrolled infections.
  • Active blood clotting disorders needing treatment.
  • History of severe liver problems after transplant.
  • Use of blood thinners that can't be safely stopped.
  • History of severe bleeding.
  • Pregnancy or breastfeeding.
  • Uncontrolled infections like Hepatitis B/C, HIV, or tuberculosis.
  • Recent use of other investigational drugs.
  • Severe side effects from transplant that haven't improved.
  • Recent heart attack or stroke.
  • Any uncontrolled medical condition that poses a risk.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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