Study of Mogamulizumab with DA-EPOCH for Aggressive T Cell Lymphoma

Sponsor: Yale University

Sponsor score: 40

ClinicalTrials ID:NCT05996185

Provider View

This clinical trial is testing a new combination of treatments for patients with aggressive T cell lymphoma, including those newly diagnosed or with cancer that has returned. The study aims to see if adding the drug mogamulizumab to standard chemotherapy can improve treatment outcomes.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for aggressive T cell lymphomas, including Adult T-cell leukemia/lymphoma (ATLL) and transformed Mycosis Fungoides/Sézary syndrome (MF/SS). The treatment combines the standard chemotherapy regimen DA-EPOCH with the drug mogamulizumab. Researchers hope this combination will be effective in achieving a high rate of complete response in patients. The treatment will be given over six cycles, and additional strategies like stem cell transplants may be considered based on the type of lymphoma. The study will involve up to 36 patients to evaluate the treatment's effectiveness.

Description

This clinical trial is testing a new treatment combination for aggressive T cell lymphomas, including Adult T-cell leukemia/lymphoma (ATLL) and transformed Mycosis Fungoides/Sézary syndrome (MF/SS). The study combines the standard chemotherapy regimen DA-EPOCH with the drug mogamulizumab. Researchers believe this combination could be effective, aiming for a complete response rate of 80%. Patients will receive six cycles of the treatment, and depending on the type of lymphoma, additional treatments like stem cell transplants may be considered. The study will monitor patients' responses at specific intervals and adjust doses if necessary. Up to 36 patients will participate to assess the treatment's effectiveness compared to historical data.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of T-cell Non-Hodgkin lymphoma (TNHL).
  • Good overall health with an ECOG performance status of 0-2, unless affected by lymphoma.
  • Diagnosed with specific types of T-cell Non-Hodgkin lymphoma, such as:
    • Peripheral T-cell lymphoma
    • Angioimmunoblastic T-cell lymphoma
    • Anaplastic large-cell lymphoma
    • Cutaneous T-cell lymphoma, including mycosis fungoides/Sezary syndrome
    • Transformed mycosis fungoides/Sezary syndrome
    • Enteropathy-associated T-cell lymphoma
    • Subcutaneous panniculitis-like T-cell lymphoma
    • Hepatosplenic T-cell lymphomas
    • Gamma delta T cell lymphomas
    • Adult T-cell lymphoma leukemia
    • T-prolymphocytic leukemia with nodal or visceral involvement
  • May have received one cycle of certain chemotherapy regimens before joining the study.
  • For peripheral T-cell lymphoma: At least one measurable tumor 1.5 cm or larger.
  • Women must not be pregnant or breastfeeding and must use effective contraception during and after treatment.
  • Men must agree to use contraception during and after treatment.
  • Adequate organ and bone marrow function, unless affected by the disease.
  • Previously treated with certain antibodies, provided CD4+ cell counts are adequate.

Exclusion Criteria

  • Recent treatment with systemic anti-cancer therapy or investigational agents within 3 weeks before starting the study.
  • Recent radiotherapy within 2 weeks before starting the study.
  • Recent major surgery without adequate recovery.
  • Use of certain immunomodulatory drugs within 4 weeks before starting the study.
  • Pregnant or breastfeeding women.
  • Recent live vaccine within 30 days before starting the study.
  • Participation in another investigational study within 4 weeks before starting the study.
  • Active uncontrolled infection requiring treatment.
  • Active myocarditis or severe heart failure.
  • Active brain metastases or carcinomatous meningitis.
  • Recent diagnosis of another malignancy, except for certain non-threatening cancers.
  • Severe allergy to mogamulizumab or EPOCH.
  • Known history of HIV, Hepatitis B, or active Hepatitis C.
  • Psychiatric or substance abuse disorders affecting study participation.
  • History of active tuberculosis.
  • Recent allogeneic stem cell transplant or active graft vs. host disease.
  • Active autoimmune disease requiring treatment.

Locations

FACILITYZIPCITYSTATE
Yale Cancer Center, Clinical Trials Office06510New HavenConnecticut

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