NCT01516567 · CITED IN SOURCE DOCUMENTS

Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2026-02-09

Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically proven Primary Mediastinal Large B-Cell Lymphoma (PMLBL). * PMLBL without central nervous system (CNS) involvement. * 6 months to less than 18 years of age at the time of consent. * Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab * Complete initial work-up within 8 days prior to treatment that allows definite staging. * Able to comply with scheduled follow-up and with management of toxicity. * Signed informed consent from patients and/or their parents or legal guardians Exclusion Criteria: * Follicular lymphoma, mucosa-associated lymphoid tissue (MALT) and nodular marginal zone * PMLBL patients with CNS involvement * Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology. * Evidence of pregnancy or lactation period. * There will be no exclusion criteria based on organ function. * Past or current anti-cancer treatment except corticosteroids during less than one week. * Tumor cell negative for CD20 * Prior exposure to rituximab. * Severe active viral infection, especially hepatitis B. * Hepatitis B carrier status history of hepatitis B virus (HBV) or positive serology. * Participation in another investigational drug clinical trial. * Patients who, for any reason, are not able to comply with the national legislation.
healthy Volunteers: false
maximum Age: 17 Years
minimum Age: 6 Months
sex: ALL
std Ages: CHILD

Treatment arms and interventions

arm Groups

description
6 courses of Dose Adjusted-EPOCH-Rituximab
intervention Names
Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
label
DA-EPOCH-R
type
EXPERIMENTAL

interventions

arm Group Labels
DA-EPOCH-R
description
6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.
name
Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 47
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from registration.
measure
Event free survival
time Frame
36 months

secondary Outcomes

description
Overall survival
measure
Survival
time Frame
5 years
description
Acute toxicity during treatment according to NCI-CTC V4
measure
Acute toxicity
time Frame
6 months
description
Long term toxicity, especially immune reconstitution, cardiac toxicity
measure
Long term toxicity
time Frame
5 years

Full study description

brief Summary: Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.

Source references

references

citation
Burke GAA, Minard-Colin V, Auperin A, Alexander S, Pillon M, Delgado R, Zsiros J, Uyttebroeck A, Dartigues P, Miles RR, Kazanowska B, Chiang AK, Haouy S, Bollard CM, Csoka M, Wheatley K, Barkauskas DA, Adamson PC, Vassal G, Patte C, Gross TG. Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial. J Clin Oncol. 2021 Nov 20;39(33):3716-3724. doi: 10.1200/JCO.21.00920. Epub 2021 Sep 27.
pmid
34570655
type
DERIVED