RecruitingPhase 2NCT05253495

Chemoradiotherapy With Targeted Immunotherapy in 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

Sponsor

New York Medical College

Enrollment

80 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

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).

Eligibility

Min Age: 3 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy, radiation, and immunotherapy for children and young adults with certain high-risk types of lymphoma — including Burkitt lymphoma, diffuse large B-cell lymphoma, and classical Hodgkin lymphoma. The goal is to improve cure rates while understanding the side effects of adding immunotherapy to standard treatment. **You may be eligible if...** - You are a child or adolescent newly diagnosed with one of the qualifying lymphoma types - Your disease falls within the trial's defined risk categories (intermediate or high risk, or with central nervous system involvement) - Your organ function is adequate to tolerate the treatment regimen **You may NOT be eligible if...** - You have primary mediastinal B-cell lymphoma, gray zone lymphoma, follicular lymphoma, or T-cell lymphoma (these are different subtypes excluded from this study) - You have previously received cancer treatment for this diagnosis - Your organ function is inadequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDOC Group B

Cyclophosphamide 300 mg x1; dexamethasone x 7; vincristine x1

DRUGPv-COMRAD 1 and 2 Group B

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

DRUGPv-R-CYM 1 and 2 Group B

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

DRUGDOC Group C

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

DRUGMAD CPR 1 and 2

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

DRUGPv-R CYVE 1 and 2

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

DRUGPv-R CYVE-MTX 1 and 2

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)

DRUGMAD CP

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

DRUGPv-Cytarabine/etoposide

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

DRUGAD CP

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

DRUGBv-AVD-R 1 and 2: COHORT IIa

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

DRUGBv-NVD-R, Cycle 1-2

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

DRUGBv-NVD-R, Cycle 1-4 SER

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

DRUGBv-AVD-R

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

DRUGBv-NVD-R, Cycle 1-4 RER

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

DRUGBv-NAVD-R, Cycle 1-2

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

RADIATIONInvolved Site Radiation Therapy

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.

Locations(3)

University of Alabama

Birmingham, Alabama, United States

University of Flordia

Gainsville, Florida, United States

New York Medical College

Vallhala, New York, United States

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NCT05253495