Ruxolitinib maintenance after stem cell transplant for T‑cell lymphoma

Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma

This phase II trial tests whether taking ruxolitinib after a stem cell transplant can lower the chance of relapse and graft‑versus‑host disease for people treated for T‑cell lymphoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University Comprehensive Cancer Center (Academic / other)
• Drugs / interventions: Ruxolitinib, radiation
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT07356245 on ClinicalTrials.gov

What this trial studies

This Phase II trial gives ruxolitinib starting between day +35 and +120 after autologous or allogeneic stem cell transplant to patients with T‑cell lymphoma in remission. The study measures relapse at 1 year for autologous transplant recipients and graft‑versus‑host disease‑free, relapse‑free survival (GRFS) at 1 year for allogeneic recipients, with secondary endpoints including progression‑free and overall survival and safety. Investigators will track incidence of acute and chronic GVHD, non‑relapse mortality, and compare outcomes to matched historical controls from the CIBMTR registry. Biospecimens and imaging/biopsies are collected to study immune reconstitution and mechanisms of relapse or GVHD.

Who should consider this trial

Good fit: Adults with T‑cell lymphoma who are in partial or complete remission between day +35 and +120 after an autologous or allogeneic stem cell transplant, with ECOG ≤2, adequate blood counts and organ function, and able to take oral medications are ideal candidates.

Not a fit: Patients with active progressive disease at the time of screening, severe organ dysfunction, uncontrolled infection, significant cytopenias that fail eligibility thresholds, or those beyond the day +120 enrollment window are unlikely to benefit from this maintenance approach.

Why it matters

Potential benefit: If successful, ruxolitinib maintenance could lower relapse rates and reduce GVHD after transplant, potentially improving survival and quality of life.

How similar studies have performed: Ruxolitinib has demonstrated benefit in treating steroid‑refractory acute and chronic GVHD and is being explored as post‑transplant maintenance, but its routine use to prevent relapse and GVHD after SCT for T‑cell lymphoma remains investigational.

Eligibility criteria

Inclusion Criteria:

1. 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 auto-SCT or allo-SCT
2. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
3. Adequate hematologic function defined by absolute neutrophil count (ANC) \> 1000/mm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets \> 50K/mm3 without transfusion for at least 3 days and hemoglobin (Hb) \> 8.0 g/dL without transfusion for at least 3 days.
4. Adequate organ function defined by total Bilirubin \< 1.5 x ULN, alanine aminotransferase (ALT) \</= 3 x ULN, CKD-EPI eGFR ≥ 30 ml/min, SpO2 \> 92% without supplemental oxygen.
5. Able to tolerate oral or enteral medications.
6. Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
7. Able to read and sign informed consent.

Exclusion Criteria:

1. Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (\<2) in first complete remission.
2. Progressive disease or any other systemic therapy post-SCT (radiation allowed)
3. Disease progression to Ruxolitinib previously
4. GvHD requiring systemic therapy.
5. Active uncontrolled infections.
6. Active thrombotic active microangiopathy requiring therapy.
7. History of veno-occlusive disorder post-transplant
8. Use of platelets antiaggregant or anticoagulants deemed to be unsafe to be held in case of thrombocytopenia.
9. History of life-threatening bleeding defined as any bleeding that required invasive procedures or involving central nervous system.
10. Pregnancy (positive Beta HCG test in a woman with childbearing potential defined as not postmenopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
11. Uncontrolled Hepatitis B/C, HIV, tuberculosis, mycobacterium, or fungal infection.
12. Exposure to other investigational drugs within 4 weeks before enrollment.
13. Grade ≥ 3 non-hematologic toxicity from SCT that has not resolved to grade ≤ 2.
14. Myocardial infarction or stroke within 1 year of study entry.
15. Any uncontrolled medical problem at the discretion of the investigator that would pose a risk to the patient.

Where this trial is running

Columbus, Ohio

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Jonathan Brammer, MD — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center

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