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Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma

RECRUITINGPhase 2Sponsored by New York Medical College
Actively Recruiting
PhasePhase 2
SponsorNew York Medical College
Started2022-02-01
Est. completion2027-12-31
Eligibility
Age3 Years – 39 Years
Healthy vol.Accepted
Locations3 sites

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

Age: 3 Years – 39 YearsHealthy volunteers accepted
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)

Conditions3

CancerHodgkin LymphomaNon-hodgkin Lymphoma

Locations3 sites

Alabama

1 site
University of Alabama
Birmingham, Alabama, 35233
Ana Xavier, MDaxavier@peds.uab.edu

Florida

1 site
University of Flordia
Gainsville, Florida, 32610
William Slayton, MDslaytwb@peds.ufl.edu

New York

1 site
New York Medical College
Vallhala, New York, 10595
Mitchell S Cairo, MD914-594-2150mitchell_cairo@nymc.edu

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