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 range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Absolute neutrophil count ≥1.0 K/mcL (Note: growth factor is allowed)
✓. 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

✕. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
✕. Pregnant women. (Lactating women must agree not to breast feed while taking study medications).
✕. Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression.

What they're measuring

Assessment for MTD/optimal dose

Timeframe: 1 year

Trial details

NCT IDNCT05010005

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Alison Moskowitz, MD

646-608-3726 moskowia@mskcc.org

View on ClinicalTrials.gov More T-cell Lymphomas trials