Ruxolitinib + Duvelisib for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will test the safety of ruxolitinib, given at one dose that does not change, and duvelisib, given at different doses, to find out what effects, if any, the study treatment has on people with relapsed or refractory NK-cell or T-cell lymphoma.This study has three parts: dose escalation (Part 1), dose expansion (Part 2), and TFH/T-PLL cohort expansion (Part 3).
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you may need to stop using certain medications that strongly affect liver enzymes (CYP3A) at least 2 weeks before starting the trial. It's best to discuss your current medications with the trial team.
Is the combination of Ruxolitinib and Duvelisib safe for humans?
Ruxolitinib is generally well tolerated, but common side effects include mild to moderate anemia (low red blood cell count), thrombocytopenia (low platelet count), and lymphopenia (low white blood cell count), which are usually manageable with dosage adjustments. Rarely, it can cause skin reactions. There is no specific safety data available for the combination with Duvelisib, but these findings provide some insight into the safety of Ruxolitinib alone.12345
What makes the drug combination of Ruxolitinib and Duvelisib unique for treating lymphoma?
What data supports the effectiveness of the drug combination Ruxolitinib and Duvelisib for treating lymphoma?
Duvelisib has been shown to be effective in treating certain types of lymphoma, such as chronic lymphocytic leukemia and follicular lymphoma, especially after other treatments have failed. It works by blocking specific proteins that help cancer cells grow. Additionally, studies suggest that combining duvelisib with other drugs can enhance its effectiveness in fighting cancer.1112131415
Who Is on the Research Team?
Alison Moskowitz, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Adults over 18 with certain types of T-cell lymphoma or leukemia, who've had at least one prior therapy (treatment-naive allowed for some conditions), can join this trial. They must be able to swallow pills, have a specific level of organ function, and not be pregnant or breastfeeding. Contraception is required during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ruxolitinib and duvelisib with dose-escalation to determine safety and optimal dosing
Cohort Expansion
Further expansion for patients with T-PLL and TFH lymphomas to evaluate disease control rate
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Duvelisib
- Ruxolitinib
Duvelisib is already approved in United States for the following indications:
- Relapsed or refractory chronic lymphocytic leukemia (CLL)
- Relapsed or refractory small lymphocytic lymphoma (SLL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor