Duvelisib Maintenance Therapy for Preventing Return of Peripheral T-Cell Lymphomas

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT07293403

Provider View

This phase II study is exploring how well the drug duvelisib works in keeping peripheral T-cell lymphomas from coming back after initial treatment. Duvelisib is a type of medication that blocks signals causing cancer cells to grow, helping to stop their spread.

Patient Parameters

Program Overview

This study is testing the effectiveness of duvelisib as a maintenance treatment for patients with peripheral T-cell lymphomas who have achieved a complete response after their first round of treatment. The goal is to see if duvelisib can help prevent the cancer from returning in patients who are not eligible for or choose not to undergo a stem cell transplant. Duvelisib works by blocking signals that cause cancer cells to multiply, potentially stopping the spread of cancer.

Description

The main goal of this study is to see how effective duvelisib is in keeping peripheral T-cell lymphoma from coming back in patients who have had a complete response to their first treatment and are not eligible for or have declined a stem cell transplant. The study will also look at how well patients tolerate the drug and their survival outcomes.

Patients will take duvelisib by mouth twice a day in 28-day cycles for up to a year, as long as the cancer does not progress and side effects are manageable. If patients continue to respond well, they may receive up to 13 additional cycles. Throughout the study, patients will have regular tests, including bone marrow biopsies, PET/CT scans, and blood tests, to monitor their health and the effectiveness of the treatment.

After finishing the treatment, patients will have follow-up visits every 4-6 weeks and then periodically for up to 5 years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Diagnosed with specific types of peripheral T-cell lymphomas.
  • Completed initial chemotherapy with a CHOP-based regimen and achieved a complete response within the last 6 months.
  • Not eligible for or have declined a stem cell transplant.
  • Recovery from previous treatment side effects to a manageable level.
  • Meet specific blood count and organ function criteria.
  • Negative tests for HIV, hepatitis B, and hepatitis C, or have these conditions under control.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for one month after the last dose.

Exclusion Criteria

  • Previous organ transplant.
  • Major surgery within the last 4 weeks.
  • Recent live vaccine.
  • Unable to take preventive treatment for certain infections.
  • Use of certain medications that affect the liver enzyme CYP3A.
  • Known involvement of the central nervous system by lymphoma.
  • Active infections or recent treatment for tuberculosis.
  • History of significant liver disease or alcohol abuse.
  • Gastrointestinal disorders that affect drug absorption.
  • Other active cancers that could interfere with the study.
  • Significant uncontrolled health conditions, such as severe heart or lung disease.
  • History of severe allergic reactions to similar drugs.
  • Currently participating in another clinical trial.
  • Pregnant or breastfeeding women.
  • Any condition that might prevent compliance with the study.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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