OncoMatch/Clinical Trials/NCT05010005
A Study of Ruxolitinib and Duvelisib in People With Lymphoma
Is NCT05010005 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Ruxolitinib and Duvelisib for t-cell lymphomas.
Treatment: Ruxolitinib · Duvelisib — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Disease stage
Required: Stage ≥IB
Stage ≥Ib CTCL, which has relapsed or progressed after at least two systemic therapies
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Stage ≥Ib CTCL, which has relapsed or progressed after at least two systemic therapies
Must have received: brentuximab vedotin-containing therapy (brentuximab vedotin)
Systemic anaplastic large cell lymphoma that has relapsed after therapy containing brentuximab vedotin
Must have received: any prior therapy
For the following histologies, patients are required to have received at least 1 prior therapy: T-cell large granular lymphocytic leukemia, Aggressive NK-cell leukemia, Adult T-cell leukemia/lymphoma, Extranodal NK/T-cell lymphoma, nasal type, Enteropathy-associated T-cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Hepatosplenic T cell lymphoma, Subcutaneous panniculitis-like T-cell lymphoma, Primary cutaneous anaplastic large cell lymphoma, Primary cutaneous gamma/delta T-cell lymphoma, Primary cutaneous CD8-positive aggressive epidermotropic cytotoxic T-cell lymphoma, Peripheral T-cell lymphoma, not otherwise specified, Angioimmunoblastic T cell lymphoma, Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with T follicular helper phenotype
Cannot have received: allogeneic stem cell transplant
Exception: allowed after discussion with MSK PI if no GVHD or immunosuppression is present at time of enrollment
Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression
Cannot have received: duvelisib or ruxolitinib (duvelisib, ruxolitinib)
Exception: if either agent was discontinued due to toxicity
Prior use of duvelisib or ruxolitinib if either agent was discontinued due to toxicity
Cannot have received: systemic anti-cancer therapy
Exception: localized RT as immediate prior therapy may be allowed with shorter washout after discussion with MSK PI; single agent ruxolitinib or duvelisib may be allowed without washout
Previous systemic anti-cancer therapy for TCL within 14 days of initiating study drug
Lab requirements
Blood counts
Absolute neutrophil count ≥1.0 K/mcL (dose escalation); ≥1.0 K/mcL or ≥0.5 K/mcL if due to lymphoma or ≥0.0 K/mcL if due to T-PLL or LGL (dose expansion); Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
Kidney function
Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Liver function
Direct bilirubin ≤1.5x ULN or ≤3x ULN if documented hepatic involvement with lymphoma, or ≤5x ULN if history of Gilbert's syndrome; AST and ALT ≤ 3x ULN; or ≤ 5x ULN if due to lymphoma involvement
Laboratory criteria: see protocol for phase-specific details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami (Data Collection Only) · Miami, Florida
- Dana Farber Cancer Institute · Boston, Massachusetts
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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