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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma, T-Cell; Cutaneous T Cell Lymphoma; Graft Versus Host Disease; T-cell Lymphoma; Peripheral T Cell Lymphoma; T-cell Prolymphocytic Leukemia; Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Adult T-cell Leukemia/Lymphoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Biopsy Procedure; Drug: Ruxolitinib; Procedure: Positron emission tomography-computed tomography

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the effect of ruxolitinib phosphate (ruxolitinib) on relapse at 1-year after autologous (auto) stem cell transplant (SCT) in T-cell lymphoma (TCL).

II. Determine the effect of ruxolitinib on graft versus host disease (GvHD) and relapse free-survival (GRFS) at 1-year for allogeneic (allo) SCT in TCL.

SECONDARY OBJECTIVES:

PRIMARY OBJECTIVES:

I. Determine the effect of ruxolitinib phosphate (ruxolitinib) on relapse at 1-year after autologous (auto) stem cell transplant (SCT) in T-cell lymphoma (TCL).

II. Determine the effect of ruxolitinib on graft versus host disease (GvHD) and relapse free-survival (GRFS) at 1-year for allogeneic (allo) SCT in TCL.

SECONDARY OBJECTIVES:

I. Survival (progression free survival [PFS]/overall survival [OS]) of patients with ruxolitinib maintenance (auto-SCT, allo-SCT, whole cohort).

II. Determine the safety and feasibility of ruxolitinib maintenance post-SCT. III. Determine the effect of ruxolitinib on the cumulative incidence (CI) of grade II-IV acute GVHD (alloSCT), chronic extensive GVHD, non-relapse mortality (NRM) (auto-SCT and allo-SCT).

EXPLORATORY OBJECTIVES:

I. Determine the effect of maintenance ruxolitinib compared to matched historical controls using the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.

II. Determine the effect of ruxolitinib on immune modulation and reconstitution post-allo-SCT and upon disease relapse.

OUTLINE:

Starting day +35 to day +120 post-SCT, patients receive ruxolitinib orally (PO) twice daily (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 positron emission tomography (PET)-computed tomography (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.

After completion of study treatment, patients are followed up at 18 and 24 months then yearly until 5 years and at progression.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 1-800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Principal Investigator: Jonathan Brammer, MD
      • Contact: Jonathan Brammer, MD; Email: Jonathan.Brammer@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (ruxolitinib maintenance); 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.

Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biospecimen Collected; Biological sampe collection; Speciment collection; Procedure: Bone Marrow Biopsy; Undergo bone marrow biopsy; Other Names: Biopsy of Bone Marrow; Biopsy; Procedure: Biopsy Procedure; Undergo tissue biopsy; Other Names: Biopsy; Drug: Ruxolitinib; Administered orally twice daily; Procedure: Positron emission tomography-computed tomography; Undergo PET-CT Scan; Other Names: PET-CT Scan; PET-CT; Computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free survival (PFS)	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 CIBMTR patients will use log-rank tests	At 1 and 2 years
Overall Survival (OS)	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 CIBMTR patients will use log-rank tests.	At 1 and 2 years
Cumulative incidence of grade II-IV acute GVHD (allo-SCT cohort)	Will be conducted using non-relapse mortality (NRM) as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis.	Up to 5 years
Cumulative incidence of chronic extensive GvHD (allo-SCT cohort)	Will be conducted using NRM as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis.	at 1 year post-SCT
Cumulative Incidence of non-relapse mortality (NRM) at 1-year after (auto-SCT, allo-SCT, whole cohort)	Will be conducted using NRM as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis	At 1 year
Rates of grade 3-4 treatment Emergent Adverse Events	Treatment-emergent adverse events of grade 3 and higher will also be reported for each cohort	Up to 2 years
Rate of patients completing 1-year post-SCT maintenance Ruxolitinib	Will be conducted using NRM as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis	At 1 year post-SCT

Collaborators and Investigators

• Sponsor: Jonathan Brammer
• Collaborators: Incyte Corporation
• Investigators: Principal Investigator: Jonathan Brammer, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: lymphoma; stem cell transplant; leukemia; graft versus host disease
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, T-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hemic and Lymphatic Diseases; Leukemia, Prolymphocytic; Leukemia; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Graft vs Host Disease; Lymphoma, T-Cell, Cutaneous; Leukemia, Prolymphocytic, T-Cell; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy; ruxolitinib
• Other Study ID Numbers: OSU-24353; NCI-2026-00140 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No