Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma

Last updated: June 10, 2025
Sponsor: New York Medical College
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Marginal Zone Lymphoma

Platelet Disorders

Treatment

DOC Group B

DOC Group C

Bv-AVD-R 1 and 2: COHORT IIa

Clinical Study ID

NCT05253495
14601
  • Ages 3-39
  • All Genders

Study Summary

The addition of targeted immunotherapy will be safe and well tolerated and facilitate the reduction of anthracycline exposure while preserving lymphoma disease control in children, adolescents and young adults (CAYA) with mature B-cell non-Hodgkin lymphoma (MB-NHL) and classical Hodgkin lymphoma (cHL).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed patients with histologically or cytologically proven newly diagnosedMB-NHL or cHL according to WHO Classification who meet the following criteria areeligible:

COHORT I:

Burkitt lymphoma (ICD-O 9687/3) Burkitt-like lymphoma with 11q aberration (ICD-O 9687/3) Diffuse large B-cell lymphoma, NOS (ICD-O 9680/3) High grade B-cell lymphoma (ICD-O 9680/3)

COHORT Ia: stage III with LDH ≥ 2 ULN OR stage IV (5-24% bone marrow lymphoma infiltration) (GROUP B)61

COHORT Ib: any CNS involvement and/or BM involvement (≥ 25% lymphoma cells) (GROUP C)61 OR patients with less than 20% tumor size reduction post chemotherapy with cyclophosphamide, dexamethasone, vincristine (DOC Reduction for Cohort Ia).

COHORT II Classical Hodgkin lymphoma (ICD-O 9650/3, 9663/3, 9651/3, 9652/3, 9653/3)

COHORT IIa: stage I-IIA with bulky ± E, I-IIB no bulky ± E, IIIA ± E (INTERMEDIATE RISK)

COHORT IIb: stage IIB with bulky ± E, IIIA with bulky ± E, IIIB, IV (HIGH RISK)

  • Adequate organ function

Exclusion

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)

Study Design

Total Participants: 80
Treatment Group(s): 17
Primary Treatment: DOC Group B
Phase: 2
Study Start date:
February 01, 2022
Estimated Completion Date:
June 30, 2028

Study Description

The primary objective is 1) to determine feasibility and safety, as defined by dose limiting toxicities (DLTs), of adding polatuzumab vedotin (Pv) in combination with rituximab (RTX) containing French-American-British (FAB) chemoimmunotherapy, with reduced dose anthracycline, in CAYA with intermediate and high risk newly diagnosed MB-NHL; 2) To define the feasibility and safety, as defined by DLTs, of the addition of nivolumab to the backbone of reduced toxicity chemoimmunotherapy with brentuximab vedotin (Bv), vinblastine, dacarbazine and rituximab, with reduced dose anthracycline, in CAYA with newly diagnosed intermediate and high risk cHL.

Connect with a study center

  • University of Alabama

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Flordia

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Flordia

    Gainsville, Florida 32610
    United States

    Active - Recruiting

  • New York Medical College

    Valhalla, New York 10595
    United States

    Site Not Available

  • New York Medical College

    Vallhala, New York 10595
    United States

    Active - Recruiting

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