RecruitingRecruiting
Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma
NCT05253495 · New York Medical College
In plain English
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Official 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
About this study
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.
Eligibility criteria
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)
Study design
Enrollment target: 80 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2022-02-01
Estimated completion: 2028-06-30
Last updated: 2025-06-13
Interventions
Drug: DOC Group BDrug: Pv-COMRAD 1 and 2 Group BDrug: Pv-R-CYM 1 and 2 Group BDrug: DOC Group CDrug: MAD CPR 1 and 2Drug: Pv-R CYVE 1 and 2Drug: Pv-R CYVE-MTX 1 and 2Drug: MAD CPDrug: Pv-Cytarabine/etoposideDrug: AD CPDrug: Bv-AVD-R 1 and 2: COHORT IIaDrug: Bv-NVD-R, Cycle 1-2Drug: Bv-NVD-R, Cycle 1-4 SERDrug: Bv-AVD-RDrug: Bv-NVD-R, Cycle 1-4 RERDrug: Bv-NAVD-R, Cycle 1-2Radiation: Involved Site Radiation Therapy
Primary outcomes
- • Grade 3 and 4 Adverse Events related to polatuzumab vedotin (1 year)
- • Grade 3 and 4 Adverse events related to nivolumab (1 year)
Sponsor
New York Medical College · other
Contacts & investigators
ContactMitchell Cairo, MD · contact · mitchell_cairo@nymc.edu · 9145942150
ContactLauren Harrison, RN · contact · lauren_harrison@nymc.edu · 617-285-7844
InvestigatorMitchell Cairo, MD · principal_investigator, New York Medical Center
All locations (3)
University of AlabamaNot Yet Recruiting
Birmingham, Alabama, United States
University of FlordiaRecruiting
Gainsville, Florida, United States
New York Medical CollegeRecruiting
Vallhala, New York, United States