Clinical trial · Interventional
Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma
Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult T-cell Leukemia/Lymphoma | Adult T-Cell Leukemia/Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Cutaneous T Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Lymphoma, T-Cell | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
| Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| T-cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy Procedure | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Bone Marrow Biopsy | Procedure | — | UNRESOLVED |
| Positron emission tomography-computed tomography | Procedure | — | UNRESOLVED |
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ruxolitinib maintenance)
- description
- 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.
- interventionNames
- Drug: Ruxolitinib
- Procedure: Positron emission tomography-computed tomography
- Procedure: Bone Marrow Biopsy
- Procedure: Biopsy Procedure
- Procedure: Biospecimen Collection
Primary outcomes (2)
- measure
- Cumulative Incidence (CI) of relapse
- timeFrame
- at 1-year post-auto-SCT
- description
- Relapse is defined as evidence of disease progression or recurrence based on Lugano criteria or confirmed by biopsy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available