A Study of Ruxolitinib and Duvelisib in People With Lymphoma (NCT05010005) | Clinical Trial Compass
RecruitingPhase 1
A Study of Ruxolitinib and Duvelisib in People With Lymphoma
United States70 participantsStarted 2021-08-12
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
. Absolute neutrophil count ≥1.0 K/mcL or ≥0.5 K/mcL if due to lymphoma or ≥0.0 K/mcL if due to T-PLL or large granular lymphocytic leukemia (LGL) (Note: growth factor is allowed).
. Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
. c. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the maximum tolerated dose of ruxolitinib and duvelisib together, what does that mean for what's currently known — and not yet known — about the safety of this specific combination in T-cell or NK-cell lymphoma?
2Given that researchers are still working out the right dose in this study, how does that level of uncertainty compare to what I might expect from standard treatment options for my type of lymphoma or leukemia?
3Both ruxolitinib and duvelisib can affect the immune system and have known side effects individually — are there particular risks I should watch for if my doctor thinks this combination trial might be worth discussing for my situation?
4How does my specific diagnosis — whether it's a T-cell lymphoma, NK-cell lymphoma, T-cell prolymphocytic leukemia, or T-cell large granular lymphocyte leukemia — affect whether this trial might even be relevant to consider?
5Since the trial is still recruiting, what would the monitoring schedule and visit frequency realistically look like, and is that something my current health situation and daily life could realistically support?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.