Actively Recruiting
Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-07-15
12
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed relapsed/refractory Peripheral T-cell lymphoma (PTCL), excluding cutaneous T-cell lymphoma (CTCL) and T-cell prolymphocytic leukemia (TPLL)
- Disease progressed during or relapsed after at least two prior therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate liver function: AST and ALT 3 times upper limit of normal, bilirubin 1.5 times upper limit of normal (unless due to Gilbert's syndrome or non-hepatic causes)
- Adequate kidney function: creatinine clearance 30 mL/min calculated by Cockcroft Gault formula or 24-hour urine collection
- Hematologic criteria at screening unless significant bone marrow involvement: absolute neutrophil count 1500 cells/mm3 (or 1000 cells/mm3 with bone marrow involvement), platelet count 50,000 cells/mm3 within 7 days of screening, hemoglobin 8 g/dL without transfusion support
You will not qualify if you...
- Eligible for hematopoietic stem cell transplantation (HSCT)
- Diagnosis of cutaneous T-cell lymphoma (CTCL) or T-cell prolymphocytic leukemia (TPLL)
- Suspected or confirmed central nervous system involvement
- Prior treatment with venetoclax or a PI3K inhibitor
- Active cancer other than non-Hodgkin lymphoma requiring treatment, except stable castration-sensitive prostate cancer
- Cancer therapy within 2 weeks before study start, except for specific targeted therapies with proper washout
- Allogeneic stem cell transplant within 6 months or active graft versus host disease needing treatment
- Active systemic infection requiring antibiotics or uncontrolled infections
- Positive tests for HIV, hepatitis B or C, or evidence of prior infection with hepatitis B or C
- Uncontrolled conditions including systemic infections, autoimmune hemolytic anemia, or immune thrombocytopenic purpura
- History of stroke, intracranial hemorrhage, or severe bleeding disorders
- Active gastrointestinal diseases requiring therapy
- Significant cardiovascular disease or recent heart events
- Use of Coumadin for blood thinning
- Pregnant or breastfeeding
- Unable to swallow capsules or have gastrointestinal conditions affecting absorption
- Use of medications or foods strongly affecting CYP3A enzymes within 7 days before treatment
- Steroid therapy exceeding 20 mg daily for cancer treatment within 7 days before treatment
- Consumption of grapefruit or certain fruits within 7 days before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
David Geffen School of Medicine at the University of California at Los Angeles
Los Angeles, California, United States, 90095-1406
Actively Recruiting
Research Team
V
Vladimir Bonhomme
CONTACT
V
Vanessa Crowell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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