Combining targeted immunotherapy with chemotherapy for pediatric lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and feasibility of adding targeted immunotherapy to standard chemotherapy regimens in children, adolescents, and young adults with newly diagnosed mature B-cell non-Hodgkin lymphoma and classical Hodgkin lymphoma. The study aims to reduce the exposure to anthracycline while maintaining effective disease control. Participants will receive a combination of polatuzumab vedotin and rituximab or nivolumab along with reduced-dose chemotherapy. The primary focus is on assessing dose-limiting toxicities to ensure patient safety.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Flordia
  Gainsville, Florida, United States Recruiting
• New York Medical College
  Vallhala, New York, United States Recruiting
• University of Alabama
  Birmingham, Alabama, United States Not yet recruiting

Study contacts

• Principal investigator: Mitchell Cairo, MD — New York Medical Center
• Study coordinator: Mitchell Cairo, MD
• Email: mitchell_cairo@nymc.edu
• Phone: 9145942150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.