OncoMatch

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.

Phase 1RecruitingMemorial Sloan Kettering Cancer CenterNCT05010005Data as of May 2026

Treatment: Ruxolitinib · DuvelisibThis 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).

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Extracted 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

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