Actively Recruiting
Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma
Led by Jonathan Brammer · Updated on 2026-04-15
44
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
J
Jonathan Brammer
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating ruxolitinib as a maintenance treatment to prevent relapse and graft-versus-host disease (GVHD) in patients with T-cell lymphoma who have undergone stem cell transplantation. GVHD occurs when donor blood cells attack the recipient's tissues after transplant. Ruxolitinib is a Janus kinase (JAK) inhibitor that may reduce immune responses and block cancer cell growth by targeting the JAK2 gene. This phase II trial aims to assess the drug's effects on relapse and GVHD outcomes at one year post-transplant. Starting between 35 and 120 days after stem cell transplant, participants take ruxolitinib orally twice daily for 30 days per cycle, repeating cycles every 30 days for one year unless disease progresses or side effects become unacceptable. Throughout the study, patients undergo PET-CT scans, blood sample collections, and may have bone marrow or tissue biopsies, especially if disease progresses. After completing treatment, patients are followed up at 18 and 24 months, then annually up to five years. Participants will be regularly assessed with imaging and laboratory tests to monitor disease status, immune function, and side effects. The primary outcomes include relapse rates and GVHD-free survival at one year. Secondary measures track progression-free and overall survival, incidence of acute and chronic GVHD, non-relapse mortality, adverse events, and treatment completion rates. This comprehensive monitoring helps evaluate the safety and feasibility of ruxolitinib maintenance after stem cell transplant.
CONDITIONS
Brief Title
Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with T-cell lymphoma (PTCL all subtypes, T-PLL, ATLL, and CTCL all subtypes) in partial or complete remission between day +35 and +120 from autologous or allogeneic stem cell transplant
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate hematologic function: absolute neutrophil count > 1000/mm3 without G-CSF for at least 3 days, platelets > 50,000/mm3 without transfusion for at least 3 days, and hemoglobin > 8.0 g/dL without transfusion for at least 3 days
- Adequate organ function: total bilirubin < 1.5 times upper limit normal, ALT ≤ 3 times upper limit normal, estimated glomerular filtration rate ≥ 30 ml/min, oxygen saturation > 92% without supplemental oxygen
- Able to tolerate oral or enteral medications
- Men and women of reproductive potential agree to use accepted birth control methods during the study; female participants must be post-menopausal, surgically sterilized, or willing to use birth control
- Able to read and sign informed consent
You will not qualify if you...
- Anaplastic lymphoma kinase (ALK)+ or DUSP22+ ALCL with low international prognostic index score (<2) in first complete remission
- Progressive disease or systemic therapy post-stem cell transplant (radiation allowed)
- Previous progression while on ruxolitinib
- Graft-versus-host disease requiring systemic therapy
- Active uncontrolled infections
- Active thrombotic microangiopathy requiring therapy
- History of veno-occlusive disorder post-transplant
- Use of platelet antiaggregant or anticoagulants unsafe to hold in thrombocytopenia
- History of life-threatening bleeding requiring invasive procedures or involving central nervous system
- Pregnancy or breastfeeding
- Uncontrolled hepatitis B/C, HIV, tuberculosis, mycobacterium, or fungal infection
- Exposure to other investigational drugs within 4 weeks before enrollment
- Grade 3 or higher non-hematologic toxicity from stem cell transplant not resolved to grade 2 or less
- Myocardial infarction or stroke within 1 year of study entry
- Any uncontrolled medical problem posing risk to patient as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year post-transplant
Participants receive ruxolitinib orally twice daily in 30-day cycles starting from day +35 to day +120 post-stem cell transplant. Treatment continues for up to 1 year post-transplant unless there is disease progression or unacceptable toxicity.
Monthly visits for up to 12 months
Duration - Up to 5 years post-transplant
After completing treatment, participants are monitored long-term to assess survival and disease status.
Visits at 18 and 24 months, then yearly until 5 years and at disease progression
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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