Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07356245

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

Led by Jonathan Brammer · Updated on 2026-04-15

44

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

Sponsors

J

Jonathan Brammer

Lead Sponsor

I

Incyte Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with T-cell lymphoma (including PTCL, T-PLL, ATLL, and CTCL) in partial or complete remission between day +35 and +120 from autologous or allogeneic stem cell transplant
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Adequate blood counts: neutrophils > 1000/mm3 without G-CSF for at least 3 days, platelets > 50,000/mm3 without transfusion for at least 3 days, and hemoglobin > 8.0 g/dL without transfusion for at least 3 days
  • Adequate organ function: total bilirubin less than 1.5 times the upper limit of normal, alanine aminotransferase (ALT) less than or equal to 3 times upper limit of normal, estimated glomerular filtration rate (eGFR) ≥ 30 ml/min, and oxygen saturation > 92% without supplemental oxygen
  • Able to tolerate oral or enteral medications
  • Men and women of reproductive potential agree to use accepted birth control methods during the study; female subjects must be post-menopausal, surgically sterilized, or willing to use acceptable contraception
  • Able to read and sign informed consent
Not Eligible

You will not qualify if you...

  • Anaplastic lymphoma kinase (ALK)+ or DUSP22+ ALCL with low international prognostic index (IPI) score (<2) in first complete remission
  • Progressive disease or any systemic therapy post-transplant (radiation allowed)
  • Previous disease progression while on ruxolitinib
  • Graft-versus-host disease requiring systemic therapy
  • Active uncontrolled infections
  • Active thrombotic microangiopathy requiring therapy
  • History of veno-occlusive disorder post-transplant
  • Use of platelet antiaggregant or anticoagulants unsafe to hold during thrombocytopenia
  • History of life-threatening bleeding requiring invasive procedures or involving the central nervous system
  • Pregnancy or currently breastfeeding; pregnancy testing 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 or higher non-hematologic toxicity from stem cell transplant not resolved to grade 2 or less
  • Myocardial infarction or stroke within 1 year before study entry
  • Any uncontrolled medical problem that poses a risk to the patient as determined by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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