Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Jonsson Comprehensive Cancer Center
Summary
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.
Description
In this phase I/II trial, we combine duvelisib and venetoclax in patients with relapsed/refractory Peripheral T-cell lymphoma (PTCL). Researchers aim to determine the maximum tolerated doses (MTD) of duvelisib in combination with venetoclax, the safety of combination therapy, and preliminary efficacy data in Peripheral T-cell lymphoma (PTCL). Patients with PTCL would be offered the option to remain on treatment beyond 2 years if they are clinically benefitting, complete response, partial response, stable disease (CR, PR, SD). The phase I portion of the trial will determine the dose, schedule…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Adequa…
Interventions
- DrugDuvelisib
15 and 25 mg BID
- DrugVenetoclax
200, 400, and 800 mg QD
Location
- David Geffen School of Medicine at the University of California at Los AngelesLos Angeles, California