Combining targeted immunotherapy with chemotherapy for pediatric lymphoma

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

This study is testing if adding a new type of immunotherapy to lower doses of chemotherapy can help children and young adults with certain types of lymphoma while keeping them safe.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 3 Years to 39 Years
• Sex: All
• Sponsor: New York Medical College (Academic / other)
• Drugs / interventions: chemotherapy, cyclophosphamide, immunotherapy, polatuzumab, rituximab, nivolumab, brentuximab
• Locations: 3 sites (Birmingham, Alabama and 2 other locations)
• Trial ID: NCT05253495 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include children, adolescents, and young adults with newly diagnosed intermediate to high-risk mature B-cell non-Hodgkin lymphoma or classical Hodgkin lymphoma.

Not a fit: Patients with low-risk lymphoma or those who have previously received treatment for these conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer treatment options with fewer side effects for young patients with lymphoma.

How similar studies have performed: Other studies have shown promise in combining immunotherapy with chemotherapy in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Birmingham, Alabama and 2 other locations

• University of Alabama — Birmingham, Alabama, United States (Not_yet_recruiting)
• University of Flordia — Gainsville, Florida, United States (Recruiting)
• New York Medical College — Vallhala, New York, United States (Recruiting)

Study contacts

• Principal investigator: Mitchell Cairo, MD — New York Medical Center
• Study coordinator: Mitchell Cairo, MD

Conditions Non-hodgkin Lymphoma; Hodgkin Lymphoma