Study on Duvelisib and Venetoclax for Patients with Difficult or Returning Peripheral T-cell Lymphoma

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT06810778

Provider View

This clinical trial is testing a new combination of two drugs, Duvelisib and Venetoclax, to see if they are safe and effective for treating Peripheral T-cell Lymphoma (PTCL) that has not responded to previous treatments or has come back.

Patient Parameters

Program Overview

This study is exploring the use of two drugs, Duvelisib and Venetoclax, in patients with Peripheral T-cell Lymphoma (PTCL) that has returned or not responded to other treatments. Duvelisib is already approved for some types of leukemia and lymphoma, while Venetoclax is approved for certain leukemia patients. However, using them together for PTCL is experimental, meaning it is not yet approved by the FDA. The main goals are to find out how safe this combination is and how well it works against the cancer.

Description

The trial is divided into two phases. In Phase I, researchers will determine the safest and most effective doses of Duvelisib and Venetoclax when used together. They will start with lower doses and gradually increase them to find the best combination. Up to 18 patients will participate in this phase, and the researchers will closely monitor for any side effects. If the combination is found to be safe, the study will move to Phase II, where more patients will be treated with the determined doses to see how well the drugs work in shrinking the cancer.

Patients who benefit from the treatment may continue it beyond two years if their cancer is stable or improving. The study will involve regular visits to the clinic for monitoring and treatment adjustments. The researchers will also exclude certain types of lymphoma due to potential risks, such as cutaneous T-cell lymphoma and T-cell-prolymphocytic leukemia.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of relapsed or refractory Peripheral T-cell Lymphoma (PTCL), excluding certain subtypes like cutaneous T-cell lymphoma and T-cell-prolymphocytic leukemia.
  • The cancer must have progressed during or returned after at least two previous treatments.
  • Be in relatively good health with an ECOG performance status of 0 to 2, meaning fully active or able to carry out light work.
  • Have adequate liver function, with specific blood test results within normal limits.
  • Have adequate kidney function, with a creatinine clearance of at least 30 mL/min.
  • Meet certain blood count criteria, unless there is significant bone marrow involvement.
  • Have a platelet count of at least 50,000 cells/mm3 and a hemoglobin level of at least 8 g/dL without recent transfusions.

Exclusion Criteria

  • Eligible for a stem cell transplant.
  • Have certain types of lymphoma, like cutaneous T-cell lymphoma or T-cell-prolymphocytic leukemia.
  • Have cancer that has spread to the brain or spinal cord.
  • Have previously been treated with Venetoclax or a PI3K inhibitor.
  • Have another active cancer requiring treatment, except for certain stable conditions.
  • Have received cancer treatment within two weeks of starting the study, with some exceptions.
  • Have had a stem cell transplant within six months or have active graft vs. host disease.
  • Have an active infection requiring antibiotics or other uncontrolled infections.
  • Test positive for HIV, hepatitis C, or hepatitis B.
  • Have uncontrolled autoimmune conditions or a history of severe bleeding disorders.
  • Have significant heart disease or recent heart problems.
  • Be pregnant or breastfeeding.
  • Have difficulty swallowing pills or have gastrointestinal issues affecting absorption.
  • Be taking certain medications or foods that interact with the study drugs, like grapefruit or strong CYP3A inhibitors or inducers.

Locations

FACILITYZIPCITYSTATE
David Geffen School of Medicine at the University of California at Los Angeles90095-1406Los AngelesCalifornia

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