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Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma

RecruitingPhase 2Ages 3 Years - 39 YearsAllNew York Medical College
NCT05253495 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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)
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What it tests

  • DOC Group B
  • Pv-COMRAD 1 and 2 Group B
  • Pv-R-CYM 1 and 2 Group B
  • DOC Group C
  • MAD CPR 1 and 2
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Where

3 sites
University of Alabama
Birmingham, United States
University of Flordia
Gainsville, United States
New York Medical College
Vallhala, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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