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(352) 733-0111

Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma (RADICAL)

  • Status
    Accepting Candidates
  • Age
    3 Years - 39 Years
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
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Objective

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).

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.

Details

Full study title Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure from Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children, Adolescents and Young Adults with Lymphoma (RADICAL)
Protocol number OCR43232
ClinicalTrials.gov ID NCT05253495
Phase Phase 2

Eligibility

Inclusion Criteria:

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

Eligible:

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 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)

Lead researcher

  • William Slayton, MD
    Pediatric Hematologist/Oncologist (Child Cancer Specialist)
    William Slayton

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    1

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    Primary contact

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