NCT07356245 · Jonathan Brammer
Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma
What this study 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.
View original scientific description
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.
Interventions
DRUG
Ruxolitinib
Administered orally twice daily
PROCEDURE
Positron emission tomography-computed tomography
Undergo PET-CT Scan
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow biopsy
PROCEDURE
Biopsy Procedure
Undergo tissue biopsy
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
Primary outcome measures
Cumulative Incidence (CI) of relapse
Time frame: at 1-year post-auto-SCT
Relapse is defined as evidence of disease progression or recurrence based on Lugano criteria or confirmed by biopsy.
GvHD and relapse free-survival (GRFS)
Time frame: at 1-year post-allo-SCT
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Columbus, Ohio
Collaborators
Incyte Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations