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Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure From Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children, Adolescents and Young Adults With Lymphoma


Description

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).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.

Trial 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)

Study Info

Organization

New York Medical College


Primary Outcome

Grade 3 and 4 Adverse Events related to polatuzumab vedotin


Outcome Timeframe 1 year

NCTID NCT05253495

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2022-02-01

Completion Date 2027-12-31

Enrollment Target 80

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

Locations Recruiting

University of Alabama

United States, Alabama, Birmingham


University of Flordia

United States, Florida, Gainesville


New York Medical College

United States, New York, Valhalla


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