Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

NCT07356245 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-24353NCI-2026-00140
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

stem cell transplant; graft versus host disease; lymphoma; leukemia

Outcome Measures

Primary Outcomes (2)

• Cumulative Incidence (CI) of relapse

  Relapse is defined as evidence of disease progression or recurrence based on Lugano criteria or confirmed by biopsy.

  at 1-year post-auto-SCT

• GvHD and relapse free-survival (GRFS)

  GRFS is a composite endpoint of survival without grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD (cGVHD), relapse, or death. Will be evaluated using the Kaplan-Meier method, with median survival and probability of surviving to relevant time points reported with point estimates and 90% confidence intervals separately for each study cohort. Comparisons to Center for International Blood and Marrow Transplant Research (CIBMTR) patients will use log-rank tests.

  at 1-year post-allo-SCT

Secondary Outcomes (7)

• Progression-Free survival (PFS)

  At 1 and 2 years

• Overall Survival (OS)

  At 1 and 2 years

• Cumulative incidence of grade II-IV acute GVHD (allo-SCT cohort)

  Up to 5 years

• Cumulative incidence of chronic extensive GvHD (allo-SCT cohort)

  at 1 year post-SCT

• Cumulative Incidence of non-relapse mortality (NRM) at 1-year after (auto-SCT, allo-SCT, whole cohort)

  At 1 year

Study Arms (1)

Treatment (ruxolitinib maintenance)

EXPERIMENTAL

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.

Drug: Ruxolitinib; Procedure: Positron emission tomography-computed tomography; Procedure: Bone Marrow Biopsy; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection

Interventions

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy

Treatment (ruxolitinib maintenance)

Ruxolitinib DRUG

Administered orally twice daily

Treatment (ruxolitinib maintenance)

Positron emission tomography-computed tomography PROCEDURE

Undergo PET-CT Scan

Also known as: PET-CT, PET-CT Scan, Computed tomography

Treatment (ruxolitinib maintenance)

Biopsy Procedure PROCEDURE

Undergo tissue biopsy

Also known as: Biopsy

Treatment (ruxolitinib maintenance)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological sampe collection, Biospecimen Collected, Speciment collection

Treatment (ruxolitinib maintenance)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
• 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.
• 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.
• Able to tolerate oral or enteral medications.
• 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.
• Able to read and sign informed consent.

You may not qualify if:

• Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (\<2) in first complete remission.
• Progressive disease or any other systemic therapy post-SCT (radiation allowed)
• Disease progression to Ruxolitinib previously
• GvHD requiring systemic therapy.
• Active uncontrolled infections.
• Active thrombotic active microangiopathy requiring therapy.
• History of veno-occlusive disorder post-transplant
• Use of platelets antiaggregant or anticoagulants deemed to be unsafe to be held in case of thrombocytopenia.
• History of life-threatening bleeding defined as any bleeding that required invasive procedures or involving central nervous system.
• 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.
• Uncontrolled Hepatitis B/C, HIV, tuberculosis, mycobacterium, or fungal infection.
• Exposure to other investigational drugs within 4 weeks before enrollment.
• Grade ≥ 3 non-hematologic toxicity from SCT that has not resolved to grade ≤ 2.
• Myocardial infarction or stroke within 1 year of study entry.
• Any uncontrolled medical problem at the discretion of the investigator that would pose a risk to the patient.

Sponsors & Collaborators

• Jonathan Brammer: lead
• Incyte Corporation: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Lymphoma, T-Cell; Graft vs Host Disease; Lymphoma, T-Cell, Peripheral; Leukemia, Prolymphocytic, T-Cell; Lymphoma, T-Cell, Cutaneous; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma; Leukemia

Interventions

ruxolitinib; Biopsy

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Prolymphocytic; Leukemia, Lymphoid; Leukemia, T-Cell; Hematologic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jonathan Brammer, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

1-800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 21, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-03

Locations

US (1)