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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment44 people
  • Recruiting US sites2
  • SponsorOhio State University Comprehensive Cancer Center
  • RegistryNCT07356245

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma: a one-minute explainerNCT073562451 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join 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.
  • Chimerism testing within 30 days of screening that shows >90% CD3 and >90% CD33 (for allo-SCT only).[
  • 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 cannot join 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

ruxolitinib phosphate. The phosphate salt form of ruxolitinib, an orally bioavailable Janus-associated kinase (JAK) inhibitor with potential antineoplastic and immunomodulating activities. Ruxolitinib specifically binds to and inhibits protein tyrosine kinases JAK 1 and 2, which may lead to a reduction in inflammation and an inhibition of cellular proliferation. The JAK-STAT (signal transducer and activator of transcription) pathway plays a key role in the signaling of many cytokines and growth factors and is involved in cellular proliferation, growth, hematopoiesis, and the immune response; JAK kinases may be upregulated in inflammatory diseases, myeloproliferative disorders, and various malignancies. NCI Drug Dictionary

Treatments listed in the registry

  • Ruxolitinib (Drug): Administered orally twice daily
  • Positron emission tomography-computed tomography (Procedure): Undergo PET-CT Scan
  • Bone Marrow Biopsy (Procedure): Undergo bone marrow biopsy
  • Biopsy Procedure (Procedure): Undergo tissue biopsy
  • Biospecimen Collection (Procedure): Undergo blood sample collection

The study

Treatment groups

Na · Single Group · masking: None

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.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • biopsy: Part of the study plan; some time points described as optional
  • bone marrow: Part of the study plan; some time points described as optional
  • blood samples: Part of the study plan
  • CT scans: Part of the study plan
  • PET scans: Part of the study plan

Goals

What the study measures

Main goals

  • Cumulative Incidence (CI) of relapse (at 1-year post-auto-SCT)
  • GvHD and relapse free-survival (GRFS) (at 1-year post-allo-SCT)

Other goals

  • Progression-Free survival (PFS)
  • Overall Survival (OS)
  • Cumulative incidence of grade II-IV acute GVHD (allo-SCT cohort)
  • Cumulative incidence of chronic extensive GvHD (allo-SCT cohort)
  • Cumulative Incidence of non-relapse mortality (NRM) at 1-year after (auto-SCT, allo-SCT, whole cohort)
  • Rates of grade 3-4 treatment Emergent Adverse Events
  • Rate of patients completing 1-year post-SCT maintenance Ruxolitinib

Planned enrollment: 44 (estimated).

Where

Recruiting US sites

  • Ohio State University Comprehensive Cancer Center, Columbus, Ohio
  • UT MD Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 26, 2026. Public record; not medical advice.

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