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NCT Number: NCT05253495

Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma

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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Key information

Conditions

Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

3 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama, Birmingham, Alabama, United States

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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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DOC Group B

Drug

Cyclophosphamide 300 mg x1; dexamethasone x 7; vincristine x1

Other names: Reduction Phase

Pv-COMRAD 1 and 2 Group B

Drug

polatuzumab vedotin x1; dexamethasone x 5; vincristine x1, cyclophosphamide x 3; doxorubicin x1; methotrexate x; rituximab 2x; ITT x1

Other names: Induction 1 and 2

Pv-R-CYM 1 and 2 Group B

Drug

polatuzumab vedotin x 1; methotrexate x 1; rituximab x 1; cytarabine x 5;

Other names: Consolidation 1 and 2

DOC Group C

Drug

cyclophosphamide x 1, dexamethasone x 5; vincristine x1; IT triples x 3

Other names: Reduction with IT

MAD CPR 1 and 2

Drug

methotrexate x 1; dexamethasone x 5; polatuzumab Vedotin x 1, cyclophosphamide x 3; doxorubicin x 1; rituximab x2; IT triples x 2 in induction 1, IT triples x 2 in induction 2

Other names: Induction 1 and 2 Group C

Pv-R CYVE 1 and 2

Drug

Polatuzumab Vedotin x 1; Rituximab x 1; Cytarabine x 5; Etoposide x4;

Other names: Consolidation 1 and 2 Group C CNS Negative

Pv-R CYVE-MTX 1 and 2

Drug

Polatuzumab Vedotin x 1; Rituximab x 1; Cytarabine x 5; Etoposide x4; high dose cytarabine x4; high dose methotrexate x 1 (only consolidation 1); IT triples x 2 (only 1 in consolidation 2)

Other names: Consolidation 1 and 2 Group C CNS Positive

MAD CP

Drug

dexamethasone x1; polatuzumab vedotin x 1; cyclophosphamide x 2; doxorubicin x 1; high dose methotrexate x 1; IT triples x 1

Other names: Maintenance 1 Group C

Pv-Cytarabine/etoposide

Drug

polatuzumab vedotin x 1; cytarabine x 5; etoposide x 3;

Other names: Maintenance 2, 4 Group C

AD CP

Drug

polatuzumab vedotin x 1; cyclophosphamide x2; doxorubicin x 2;

Other names: Maintenance 3 Group C

Bv-AVD-R 1 and 2: COHORT IIa

Drug

brentuximab vedotin x 2; doxorubicin x 2; vinblastine x 2; dacarbazine 2x; rituximab x 2

Other names: Intermediate Risk cohort IIa

Bv-NVD-R, Cycle 1-2

Drug

brentuximab vedotin x 2; nivolumab x 2; vinblastine x2; dacarbazine x 2; rituximab x 2;

Other names: Cohort IIa Rapid Early Responders

Bv-NVD-R, Cycle 1-4 SER

Drug

brentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; rituximab x 2;

Other names: Cohort IIa Slow Early Responders

Bv-AVD-R

Drug

Brentuximab vedotin x2; doxorubicin x2; vinblastine x 2; dacarbazine x 2; rituximab x2;

Other names: High-Risk cohort IIb

Bv-NVD-R, Cycle 1-4 RER

Drug

brentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;

Other names: cohort IIb Rapid Early Responders

Bv-NAVD-R, Cycle 1-2

Drug

brentuximab vedotin x 2; nivolumab x 2; doxorubicin x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;

Other names: cohort IIb Slow Early Responders

Involved Site Radiation Therapy

Radiation

21 Gy in 14 fractions of 1.50 Gy per day. The treatment will be given 5 days per week. All fields shall be treated once each day. The total elapsed treatment time will be 2.8 weeks (14 sessions) for each field.

Other names: Cohort II ONLY

Primary outcomes

  1. Grade 3 and 4 Adverse Events related to polatuzumab vedotin

    Time frame: 1 year

    to evaluate the DLTs of polatuzumab vedotin (Pv) in combination with rituximab (RTX) containing French-American-British (FAB) chemoimmunotherapy, with reduced dose anthracycline to MB-NHL

  2. Grade 3 and 4 Adverse events related to nivolumab

    Time frame: 1 year

    To evaluate the DLTs of nivolumab to the backbone of reduced toxicity chemoimmunotherapy with brentuximab vedotin (Bv), vinblastine, dacarbazine and rituximab, with reduced dose anthracycline in intermediate and high risk cHL

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Harrison, RN

CONTACT

[email protected]

617-285-7844

Mitchell Cairo, MD

CONTACT

[email protected]

9145942150

Sponsors and collaborators

Lead sponsor

New York Medical College

Other

Registry information

Official study 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

Acronym: RADICAL

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 23, 2022
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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