Ruxolitinib maintenance after stem cell transplant for T‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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. Chimerism testing within 30 days of screening that shows \>90% CD3 and \>90% CD33 (for allo-SCT only).\[
6. Able to tolerate oral or enteral medications.
7. 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.
8. 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 it's running

• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting
• UT MD Anderson Cancer Center
  Houston, Texas, 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
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 1-800-293-5066

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study is testing if the drug Ruxolitinib can help prevent complications like graft-versus-host disease in patients receiving stem cell transplants from partially matched donors.

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• Registry for individuals with T-cell lymphoma

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• Testing a new treatment for relapsed T-cell non-Hodgkin lymphoma

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• Non-Hodgkin Lymphoma Sample Collection for MRD Testing

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• Ruxolitinib for Graft-Versus-Host Disease in Clinical Practice

  This study tests how well Jakavi (ruxolitinib) works and how safe it is for people with acute or chronic GVHD being treated in real-world medical settings.

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• Azacitidine and abatacept for relapsed or refractory T-cell lymphoma

  This study tests a combination of azacitidine and abatacept to see if it can shrink tumors in adults whose T-cell lymphoma has come back or not responded to treatment.

  Recruiting Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07388563

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.