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

Recruiting now · Phase 1/Phase 2

Conditions studied: T-cell-prolymphocytic Leukemia, Cutaneous T-Cell Lymphoma Refractory

In brief

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 facts

Study ID: NCT06810778
Run by: Jonsson Comprehensive Cancer Center
People needed: 12
Starts: 2025-05-02
Expected to finish: 2031-06-01
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
o Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
Adequate renal function as defined by:
o Creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection
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.)

You may not qualify if…

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
o Patients with a history of an allogeneic stem cell transplant > 6 months prior to starting study treatment should be stable, off of immunosuppression for at least 2 months.
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
o For HCV and HBV, patients with evidence of prior infection also excluded
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

Where it is running

David Geffen School of Medicine at the University of California at Los Angeles — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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