Ruxolitinib for T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how well ruxolitinib can prevent relapse and graft-versus-host disease (GVHD) in individuals with T-cell lymphoma after a stem cell transplant. Ruxolitinib calms the immune response and blocks cancer cell growth. Suitable candidates have T-cell lymphoma, are in partial or complete remission, and have recently undergone a stem cell transplant. The trial aims to determine if ruxolitinib can effectively prevent donor cells from attacking the patient's body while stopping cancer recurrence. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that ruxolitinib is likely to be safe for humans?
Research has shown that ruxolitinib, a drug used to treat T-cell lymphoma, is generally safe for patients. In earlier studies, the most common side effects included anemia (a low count of red blood cells) and thrombocytopenia (a low count of platelets), occurring because the drug affects blood cell production.
One study found that 42.4% of patients experienced side effects, but most recovered, and only one person discontinued treatment due to these effects. Ruxolitinib has proven effective in treating various types of T-cell lymphoma, suggesting it could be a promising option for many patients.
While side effects are a consideration, the ongoing phase 2 trial indicates some existing evidence of its safety in humans. This phase aims to further assess how well people tolerate the drug.12345Why do researchers think this study treatment might be promising?
Ruxolitinib is unique because it targets the JAK-STAT pathway, which plays a crucial role in the survival and proliferation of T-cell lymphoma cells. Unlike traditional chemotherapy or radiation therapies that attack cancer cells broadly, ruxolitinib offers a more targeted approach by specifically inhibiting this pathway. Researchers are excited about this treatment due to its potential for fewer side effects and its novel mechanism of action, which could offer a new line of attack against T-cell lymphoma.
What evidence suggests that ruxolitinib might be an effective treatment for preventing relapse and GVHD in T-cell lymphoma patients?
Research shows that ruxolitinib, the treatment under study in this trial, may help treat T-cell lymphomas. Studies have found it effective in about 50% of patients, particularly those with genetic traits like JAK/STAT mutations. This drug blocks signals that promote cancer cell growth. Ruxolitinib has shown benefits across various types of T-cell lymphomas, making it a promising treatment option. Overall, these findings suggest that ruxolitinib could help prevent cancer recurrence and manage graft-versus-host disease (GVHD) after stem cell transplants.15678
Who Is on the Research Team?
Jonathan Brammer, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Adults with T-cell lymphoma in partial/complete remission post-stem cell transplant can join. They must be fairly active (ECOG ≤2), have stable blood counts without recent transfusions, normal organ function, and agree to use birth control. Ineligible if they can't take oral meds or sign consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ruxolitinib orally twice daily starting day +35 to day +120 post-SCT, with cycles repeating every 30 days for 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 18 and 24 months, then yearly until 5 years and at progression
What Are the Treatments Tested in This Trial?
Interventions
- Ruxolitinib
Trial Overview
The trial is testing Ruxolitinib as a maintenance drug to prevent relapse and GVHD after stem cell transplantation for T-cell lymphoma. It's a phase II study assessing the effectiveness of this JAK inhibitor in reducing immune response and cancer growth.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonathan Brammer
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Citations
A phase 2 biomarker-driven study of ruxolitinib ...
They demonstrate meaningful benefit in approximately 50% of patients whose PTCL carries activating JAK and/or STAT mutations or has immunohistochemical evidence ...
2.
lymphomahub.com
lymphomahub.com/medical-information/the-efficacy-and-safety-of-the-jak-12-inhibitor-ruxolitinib-in-tclThe efficacy and safety of the JAK 1/2 inhibitor ruxolitinib in ...
Ruxolitinib response was promising for T-PLL, with a CBR of 50% across patients harboring JAK/STAT mutations (n = 7) and one patient with only pSTAT3 ...
3.
hematologyadvisor.com
hematologyadvisor.com/news/ruxolitinib-appears-effective-across-peripheral-t-cell-lymphoma-sybtypes/Ruxolitinib Appears Effective Across Peripheral T-Cell ...
Researchers have demonstrated that ruxolitinib appears to be clinically efficacious across a variety of peripheral T-cell lymphoma (PTCL) subtypes.
Dual-Targeted Therapy with Ruxolitinib Plus Duvelisib for T ...
All enrolled patients were response evaluable and the overall response rate (ORR) was 41%, complete response (CR) rate 24%, and partial response ...
A phase 2 biomarker-driven study of ruxolitinib demonstrates ...
Ruxolitinib is clinically efficacious across various T-cell lymphoma subtypes, especially T-LGL. Ruxolitinib activity is enriched among PTCL with JAK/STAT ...
Safety and efficacy of ruxolitinib in an open ...
Consistent with the mechanism of action of ruxolitinib, the most common adverse events were anemia and thrombocytopenia; however, these adverse events were ...
NCT01712659 | Ruxolitinib for Adult T-Cell Leukemia
Clinical and correlative laboratory data demonstrated limited inhibition and impact on the subject's disease with the standard 20 mg twice daily dose. Given ...
A phase II study of the oral JAK1/JAK2 inhibitor ruxolitinib ...
Forty adverse events were reported in 14/33 patients (42.4%). One event led to treatment discontinuation, while 87.5% of patients recovered ...
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