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New treatment option for T-cell Lymphoma
Official title Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma
ClinicalTrials.gov ID: NCT07356245
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- 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...
- Adequate organ function defined by total Bilirubin \ 92% without supplemental oxygen.
- Able to tolerate oral or enteral medications.
You likely can't join if
- Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (\<2) in first complete...
- 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.
See the full eligibility 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...
- Adequate organ function defined by total Bilirubin \ 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...
- Able to read and sign informed consent.
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.