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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Blood draws, CT scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ruxolitinib can help keep T-cell lymphoma from coming back after a stem cell transplant. It also tests whether the drug can prevent graft-versus-host disease (GVHD), when donor cells attack the body. It is for adults whose cancer has partly or fully improved after transplant.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have one of the listed T-cell cancers: PTCL, T-PLL, ATLL, or CTCL. Cancer must have partly or fully improved, and the transplant must have been 35–120 days ago.
  • Had a transplant using your own stem cells or donor stem cells.
  • Can care for yourself and are out of bed or a chair for at least half the day.
  • Have blood counts above the study limits, without certain white blood cell growth drugs or blood transfusions for at least 3 days.
  • Meet the study’s liver and kidney test limits. Blood oxygen must be above 92% without extra oxygen.
  • Can take medicine by mouth or through a feeding tube.
  • Agree to use an accepted birth control method during the study if you can have or father a child.
  • Can read and sign the study consent form.

Who can't join

  • Have ALCL, a type of lymphoma, with an ALK-positive or DUSP22-positive test, a low risk score (IPI below 2), and a first full remission.
  • Cancer is getting worse, previously worsened while taking ruxolitinib, or was treated with another whole-body cancer treatment after transplant. Radiation is allowed.
  • Have GVHD that needs whole-body treatment, or severe transplant side effects outside the blood that have not improved enough.
  • Have an active infection that is not controlled, including hepatitis B or C, HIV, tuberculosis, other mycobacterial infections, or fungal infections.
  • Have small-blood-vessel damage with clots that needs treatment, or had blocked liver veins after transplant.
  • Take blood-thinning medicines that cannot safely be stopped if platelets become low, or have had life-threatening bleeding requiring a procedure or involving the brain or spinal cord.
  • Are pregnant or breastfeeding, or used another experimental drug within 4 weeks before joining.
  • Had a heart attack or stroke within the past year, or have another uncontrolled health problem that the study doctor believes makes joining unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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