Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma

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).

Conditions

• Non-hodgkin Lymphoma
• Hodgkin Lymphoma

Interventions

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.

Sponsors & Collaborators

• New York Medical College

  lead OTHER

Principal Investigators

• Mitchell Cairo, MD · New York Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-01

Primary Completion

2027-12-31

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States

Study Locations