Study on Adding Duvelisib or CC-486 to Standard Treatment for Peripheral T-Cell Lymphoma

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04803201

Provider View

This clinical trial is exploring whether adding the drugs Duvelisib or CC-486 to the usual chemotherapy can improve treatment outcomes for patients with peripheral T-cell lymphoma. The study aims to determine if this new approach is more effective than the standard treatment alone.

Patient Parameters

Program Overview

This phase II study is testing the effects of adding Duvelisib or CC-486 to the usual chemotherapy regimen for patients with peripheral T-cell lymphoma. Duvelisib may help stop cancer cells from growing by blocking certain enzymes. The chemotherapy drugs used in this study work in different ways to kill cancer cells, stop them from dividing, or prevent them from spreading. The trial will help determine if this new combination is better or worse than the standard treatment for peripheral T-cell lymphoma.

Description

The main goal of this study is to compare how well patients achieve complete remission (no signs of cancer) after treatment with either Duvelisib or CC-486 added to the usual chemotherapy, compared to the usual chemotherapy alone. The study will also look at the safety and side effects of these treatments, as well as how long patients respond to treatment, how long they live without the cancer getting worse, and their overall survival.

Patients in the study will be randomly assigned to one of three groups:

  • Group A: Patients will receive the usual chemotherapy drugs (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone) along with Duvelisib. This treatment will be given in cycles every 21 days, for up to 6 cycles, unless the cancer progresses or side effects become too severe.

  • Group B: Patients will receive the usual chemotherapy drugs along with CC-486. This treatment will also be given in cycles every 21 days, for up to 6 cycles, unless the cancer progresses or side effects become too severe.

  • Group C: Patients will receive only the usual chemotherapy drugs. This treatment will be given in cycles every 21 days, for up to 6 cycles, unless the cancer progresses or side effects become too severe.

After completing the treatment, patients will be monitored at 6 weeks after the last cycle, then every 12 weeks for 2 years, and every 24 weeks until 5 years after treatment or until the cancer progresses. If the cancer progresses, follow-up will occur every 6 months until 5 years after treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with peripheral T-cell lymphoma with less than 10% CD30 expression.
  • No previous systemic treatment for lymphoma, except corticosteroids.
  • Age 18 years or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate blood cell counts and organ function.
  • Not pregnant or nursing, and willing to use contraception if of childbearing potential.
  • No active infections like HIV, hepatitis B, or hepatitis C, unless well-controlled.
  • No other active cancers requiring treatment in the last 3 years, except certain skin cancers or localized prostate cancer.
  • No significant heart disease in the last 6 months.
  • Able to provide a tumor tissue sample for analysis.
  • No known central nervous system involvement by lymphoma.
  • No active uncontrolled infections.
  • No contraindications to the chemotherapy drugs used in the study.

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