Duvelisib + Venetoclax for T-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Jonsson Comprehensive Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with various types of T-cell lymphoma, including cutaneous and peripheral forms, who have not responded to previous treatments. Participants must meet specific health criteria to be eligible.

Inclusion Criteria

My condition worsened after two prior treatments.

I can take care of myself but might not be able to do heavy physical work.

My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).

My lymphoma has returned or didn't respond to treatment, but it's not skin or prolymphocytic leukemia.

Exclusion Criteria

I have been diagnosed with CTCL or TPLL.

My cancer has spread to my brain or spinal cord.

I have been treated with venetoclax or a PI3K inhibitor before.

I have cancer other than non-Hodgkin lymphoma that doesn't need treatment except for hormone therapy.

I am eligible for a stem cell transplant.

I had a stem cell transplant from a donor within the last 6 months or I am being treated for GVHD.

I do not have any infections that require antibiotics.

I have tested positive for HIV, HCV, or HBV.

I do not have uncontrolled health issues or take conflicting medications.

Participant Groups

The study tests a combination of two drugs: Duvelisib, approved for leukemia and lymphoma treatment; and Venetoclax, approved for acute myeloid leukemia. Their combined effect on T-cell lymphoma is being evaluated.

1Treatment groups

Experimental Treatment

Group I: Arm Treatment (Duvelisib and Venetoclax)Experimental Treatment2 Interventions

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.