Status:
RECRUITING
Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma
Lead Sponsor:
New York Medical College
Conditions:
Non-hodgkin Lymphoma
Hodgkin Lymphoma
Eligibility:
All Genders
3-39 years
Phase:
PHASE2
Brief 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 you...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05253495
Start Date
February 1 2022
End Date
June 30 2028
Last Update
June 13 2025
Active Locations (3)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
University of Flordia
Gainsville, Florida, United States, 32610
3
New York Medical College
Vallhala, New York, United States, 10595