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Duvelisib and Venetoclax for Relapsed or Refractory PTCL

This study is testing a combination of two drugs, duvelisib and venetoclax, for people with peripheral T-cell lymphoma (PTCL) that has come back or hasn't responded to other treatments. Duvelisib is already approved for some leukemias and lymphomas, and venetoclax is approved for a type of leukemia. Combining them is experimental, meaning it's not yet approved by the FDA. Researchers want to find the safest dose of this combination and see how well it works against your cancer. You may be able to join if you are 18 or older and have PTCL that has progressed after at least two previous therapies. The study is currently unclear on its status and plans to enroll up to 12 participants.

Study design
This is an open-label, Phase I/II study, meaning you and your doctors will know which drugs you are receiving. The Phase I part will test different doses of duvelisib and venetoclax, with up to 18 patients planned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for safety and dose determination are measured up to 21 days. Patients who are clinically benefiting may remain on treatment beyond 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06810778

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~12 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:DuvelisibVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the dose limiting toxicities (DLTs), for the combination regimen of duvelisib plus venetoclax for patients with relapsed or refractory PTCL
Measured over Up to 21 days
+2 more outcomes measured

Conditions

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

Explore related trials

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NCT06810778

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • David Geffen School of Medicine at the University of California at Los Angeles

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Vladimir Bonhomme
[email protected]
310-794-6500
Email the study team

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Eligibility criteria

Inclusion

Phase I: Histologically confirmed relapsed/refractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL).
Phase II: same as phase I
Disease that has progressed during or relapsed after at least two previous therapies.
ECOG performance status ≤ 2
Adequate hepatic function defined as:
Adequate renal function as defined by:
Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement confirmed on biopsy:
Absolute neutrophil count ≥ 1500 cells/mm3 (1.5 x 109/L) or ≥ 1000 cells/mm3 (1.5 x 109/L) with bone marrow involvement. Growth factor use is allowed in order to achieve this
Platelet count ≥ 50,000 cells/mm3 (50 x 109/L) independent of transfusion within 7 days of screening
Hemoglobin ≥8 g/dL (without transfusion support.)

Exclusion

Phase I and Phase II:
Patients eligible for Hematopoietic stem cell transplantation (HSCT)
Cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL)
Suspected and confirmed central nervous system involvement
Previous treatment with venetoclax or a PI3K inhibitor.
Active malignancy other than NHL requiring ongoing therapy, with the exception of hormonal therapy (i.e. castration-sensitive prostate cancer stable on testosterone blockade)
Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery) within 2 weeks of Cycle 1/Day 1 with the following exceptions:
For patients on targeted therapies, a washout of least five half-lives is required
Patients who experience clinical deterioration may start therapy after a shorter washout period with prior approval by the PI
Corticosteroid therapy (prednisone or equivalent \<20 mg daily) is allowed
Patients with multiple basal cell carcinomas that undergo sequential Moh's excisions with interim observation
Allogeneic hematologic stem cell transplant within 6 months of starting study treatment or active graft vs. host disease (GVHD) requiring treatment or prophylaxis
Any active systemic infection requiring systemic antibiotics or other uncontrolled, active infections
Positive Human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) antibody test
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate
Uncontrolled, not disease-related autoimmune hemolytic anemia or ITP
History of stroke or intracranial hemorrhage
History of severe bleeding disorder (hemophilia A or B, von Willebrand disease (VWD)), history of spontaneous bleeding requiring blood transfusions or other medical intervention, history of life-threatening hemorrhage within 3 months of first dose.
Currently active gastrointestinal disease, including colitis, inflammatory bowel disease and diarrhea requiring therapy
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina
Use of Coumadin for anticoagulation (other anticoagulants permitted)
Lactating or pregnant
Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction resulting in malabsorption or chronic diarrhea
Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A (see Appendix D)
Treatment with any of the following within 7 days prior to the first dose of study drug:
Steroid therapy for anti-neoplastic intent (defined as prednisone or equivalent \>20 mg daily)
Moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix D for examples)
Moderate or strong CYP3A inducers (see Appendix D for examples)
Administration or consumption of any of the following within 7 days prior to the first dose of study drug:
Grapefruit or grapefruit products
Seville oranges (including marmalade containing Seville oranges)
Star fruit

What this trial measures

  • Determine the dose limiting toxicities (DLTs), for the combination regimen of duvelisib plus venetoclax for patients with relapsed or refractory PTCLUp to 21 days

    Phase I: Will be graded according to the Common Terminology Criteria for Adverse Events version 5.0.

  • Determine the Maximum Tolerated Dose MTD)Up to 21 days

    Phase I: Will be defined as the highest dose studied for which the observed incidence of DLT is less than 33%. Frequencies of toxicities will be tabulated according to the National Cancer Institute Common Toxicity Criteria.

  • Recommended phase II dose (Phase I)Up to 21 days

    Phase I