NCT05253495PHASE2Recruiting

Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma

New York Medical College

Start Date

2/1/2022

Completion Date

6/30/2028

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).

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-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

Age Range: 3 years to 39 years

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)

Interventions

DRUG

DOC Group B

DRUG

Pv-COMRAD 1 and 2 Group B

DRUG

Pv-R-CYM 1 and 2 Group B

DRUG

DOC Group C

DRUG

MAD CPR 1 and 2

DRUG

Pv-R CYVE 1 and 2

DRUG

Pv-R CYVE-MTX 1 and 2

DRUG

MAD CP

DRUG

Pv-Cytarabine/etoposide

DRUG

AD CP

DRUG

Bv-AVD-R 1 and 2: COHORT IIa

DRUG

Bv-NVD-R, Cycle 1-2

DRUG

Bv-NVD-R, Cycle 1-4 SER

DRUG

Bv-AVD-R

DRUG

Bv-NVD-R, Cycle 1-4 RER

DRUG

Bv-NAVD-R, Cycle 1-2

RADIATION

Involved Site Radiation Therapy

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Non-hodgkin LymphomaHodgkin Lymphoma

Locations

University of Alabama

Birmingham, Alabama 35233

United States

University of Flordia

Gainsville, Florida 32610

United States

New York Medical College

Vallhala, New York 10595

United States