NCT05253495

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 3 Years – 39 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Non-hodgkin Lymphoma
• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	DOC Group B	Cyclophosphamide 300 mg x1; dexamethasone x 7; vincristine x1
DRUG	Pv-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
DRUG	Pv-R-CYM 1 and 2 Group B	polatuzumab vedotin x 1; methotrexate x 1; rituximab x 1; cytarabine x 5;
DRUG	DOC Group C	cyclophosphamide x 1, dexamethasone x 5; vincristine x1; IT triples x 3
DRUG	MAD 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
DRUG	Pv-R CYVE 1 and 2	Polatuzumab Vedotin x 1; Rituximab x 1; Cytarabine x 5; Etoposide x4;
DRUG	Pv-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)
DRUG	MAD CP	dexamethasone x1; polatuzumab vedotin x 1; cyclophosphamide x 2; doxorubicin x 1; high dose methotrexate x 1; IT triples x 1
DRUG	Pv-Cytarabine/etoposide	polatuzumab vedotin x 1; cytarabine x 5; etoposide x 3;
DRUG	AD CP	polatuzumab vedotin x 1; cyclophosphamide x2; doxorubicin x 2;
DRUG	Bv-AVD-R 1 and 2: COHORT IIa	brentuximab vedotin x 2; doxorubicin x 2; vinblastine x 2; dacarbazine 2x; rituximab x 2
DRUG	Bv-NVD-R, Cycle 1-2	brentuximab vedotin x 2; nivolumab x 2; vinblastine x2; dacarbazine x 2; rituximab x 2;
DRUG	Bv-NVD-R, Cycle 1-4 SER	brentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; rituximab x 2;
DRUG	Bv-AVD-R	Brentuximab vedotin x2; doxorubicin x2; vinblastine x 2; dacarbazine x 2; rituximab x2;
DRUG	Bv-NVD-R, Cycle 1-4 RER	brentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;
DRUG	Bv-NAVD-R, Cycle 1-2	brentuximab vedotin x 2; nivolumab x 2; doxorubicin x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;
RADIATION	Involved 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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2022-02-23
• Last updated: 2025-06-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study