Study on Chemoradiotherapy with Targeted Immunotherapy for Pediatric Lymphoma

Sponsor: New York Medical College

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05253495

Provider View

This clinical trial is exploring whether adding targeted immunotherapy to standard treatment can safely reduce the use of certain chemotherapy drugs while still effectively controlling lymphoma in children, adolescents, and young adults with specific types of lymphoma.

Patient Parameters

Program Overview

The study aims to find out if adding targeted immunotherapy to the usual treatment can help control lymphoma in young patients while reducing the need for certain chemotherapy drugs that can have strong side effects. This approach is being tested in children, adolescents, and young adults with mature B-cell non-Hodgkin lymphoma (MB-NHL) and classical Hodgkin lymphoma (cHL).

Description

The main goal of this study is to see if adding a new type of immunotherapy to the standard treatment is safe and can be done without causing serious side effects. For patients with intermediate and high-risk mature B-cell non-Hodgkin lymphoma (MB-NHL), the study will test the addition of polatuzumab vedotin and rituximab to the usual chemotherapy, but with a lower dose of anthracycline. For those with intermediate and high-risk classical Hodgkin lymphoma (cHL), the study will test adding nivolumab to a treatment plan that includes brentuximab vedotin, vinblastine, dacarbazine, and rituximab, again with a reduced dose of anthracycline.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with specific types of lymphoma, including mature B-cell non-Hodgkin lymphoma (MB-NHL) or classical Hodgkin lymphoma (cHL).
  • For MB-NHL:
    • Burkitt lymphoma or similar types.
    • Stage III with high LDH levels or Stage IV with some bone marrow involvement.
    • Any central nervous system involvement or significant bone marrow involvement.
    • Less than 20% tumor reduction after initial chemotherapy.
  • For cHL:
    • Stage I-IIA with or without bulky disease, or Stage I-IIB without bulky disease.
    • Stage IIB with bulky disease, Stage IIIA with bulky disease, or Stage IIIB and IV.
  • Must have adequate organ function.

Exclusion Criteria

  • Primary mediastinal B-cell lymphoma (PMBL).
  • T-cell/histiocyte-rich large B-cell lymphoma.
  • Gray zone lymphoma.
  • Follicular lymphoma.
  • Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL).
  • Posttransplant lymphoproliferative lymphoma (PTLD).

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