Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT06810778
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cutaneous T-Cell Lymphoma Refractory
  • T-cell-prolymphocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Duvelisib — DRUG
    15 and 25 mg BID
  • Venetoclax — DRUG
    200, 400, and 800 mg QD

Study Details

This is an open-label, phase I/II study of duvelisib in combination with Venetoclax for patients with relapsed/refractory NHL. Duvelisib is an FDA approved, marketed product used to treat certain patients with leukemia and lymphoma and Venetoclax, which is approved for treatment of certain patients with acute myeloid leukemia. The combination of these two drugs is experimental. Experimental means that it is not approved by the United States Food and Drug Administration (FDA). The researchers want to find out how safe it is to combine these drugs and how well this combination can work for your cancer.

Key Dates

Start date
May 2, 2025
Status verified
Jul 2025
Primary completion
Jun 1, 2030
Completion
Jun 1, 2031

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm Treatment (Duvelisib and Venetoclax)
    Phase I: In the phase I study, 2 dose levels of duvelisib (15 and 25 mg BID) and 3 dose levels of venetoclax (200, 400, and 800 mg QD) will be evaluated. Patients will start with 15 mg BID of duvelisib and 200 mg QD of venetoclax. We use a traditional 3 + 3 design to accrue patients to each combination cohort. There are 5 possible dosing combinations to be tested, with up to 18 patients planned to be enrolled. Enrollment may stop early based on DLTs. The DLT assessment window is defined as Day 1-21 of Cycle 1 (21 days). De-escalation will occur if unexpected toxicity is observed and both drugs will be reduced for the next lower dosing cohort. Increasing drug dosing levels will be performed in parallel cohorts, each increasing either venetoclax or duvelisib.

Primary Outcome Measure

Determine the dose limiting toxicities (DLTs), for the combination regimen of duvelisib plus venetoclax for patients with relapsed or refractory PTCL [ Time Frame: Up to 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
David Geffen School of Medicine at the University of California at Los AngelesLos AngelesCalifornia90095-1406
Vanessa Crowell
[email protected]
424-440-0843
Vladimir Bonhomme
[email protected]
310-794-6500
Sven de Vos, MD, PhD (PRINCIPAL_INVESTIGATOR)
John Timmerman, MD (SUB_INVESTIGATOR)
Patricia Young, MD (SUB_INVESTIGATOR)

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By research site
David Geffen School of Medicine at the University of California at Los Angeles· Los Angeles, CA

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