Study on Tazemetostat Combined with CHOP Chemotherapy for First-Line Treatment of T-Cell Lymphoma

Sponsor: Eric Jacobsen, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06692452

Provider View

This clinical trial is exploring whether adding the drug tazemetostat to the standard chemotherapy regimen CHOP can improve treatment outcomes for patients with peripheral T-cell lymphoma (PTCL).

Patient Parameters

Program Overview

The purpose of this study is to test if combining tazemetostat with the standard chemotherapy treatment known as CHOP can be an effective treatment for peripheral T-cell lymphoma (PTCL). Tazemetostat is a drug that targets specific proteins that may be overactive in PTCL. The study will involve various procedures, including blood tests, scans, and biopsies, to monitor the treatment's effects. About 24 people are expected to participate in this study, which is supported by Ipsen, the company providing the study drug.

Description

This study is a phase 2 trial to see if adding tazemetostat to the usual chemotherapy treatment (CHOP) is more effective for treating peripheral T-cell lymphoma (PTCL) than the standard approach. CHOP is a combination of four drugs: cyclophosphamide, doxorubicin, vincristine, and prednisone. Tazemetostat is not yet approved by the FDA for PTCL but is approved for other types of cancer. Participants will undergo various tests and procedures, including blood tests, heart tests, and scans, to assess the treatment's impact. The study is open-label, meaning both the researchers and participants know which treatment is being given. Ipsen is providing the drug and funding for the study.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of peripheral T-cell lymphoma of specific subtypes.
  • No prior treatment for T-cell lymphoma, except for one cycle of CHOP or CHOEP or short-term corticosteroids for symptom relief.
  • Must have at least one measurable tumor.
  • Age 18 or older.
  • Must be in relatively good health with a performance status score of 2 or less.
  • Must have adequate organ and bone marrow function, as shown by specific blood test results.
  • Cannot have HIV infection.
  • If there is a history of hepatitis B, the virus must be undetectable with treatment.
  • If there is a history of hepatitis C, it must have been treated and cured.
  • Must have good heart function.
  • Women of childbearing potential and men must agree to use effective birth control during the study and for a period after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have had prior chemotherapy for T-cell lymphoma, except for one cycle of CHOP/CHOEP.
  • Cannot be taking other experimental drugs.
  • Cannot have lymphoma in the central nervous system.
  • Cannot have allergies to similar drugs used in the study.
  • Cannot have had an organ transplant.
  • Cannot have severe nerve damage.
  • Cannot have other cancers that could interfere with the study, except for certain skin cancers or early-stage prostate cancer.
  • Cannot have uncontrolled illnesses.
  • Pregnant or breastfeeding women cannot participate.
  • Cannot have significant heart disease or recent major surgery.
  • Cannot have active infections.
  • Must be able to swallow pills.
  • Children under 18 are not eligible for this study.

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