Clinical trial NCT01516567: Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
Official title: Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Primary Mediastinal Large B Cell Lymphoma
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: Children's Oncology Group
First posted: 2012-01-25
Enrollment: 47
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Event free survival
timeFrame: 36 months
Secondary outcomes:
measure: Survival
timeFrame: 5 years
measure: Acute toxicity
timeFrame: 6 months
measure: Long term toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Monrovia
country: Canada
facility: Children Oncology Group Operations centres
city: Villejuif
country: France
facility: Gustave Roussy
city: Budapest
country: Hungary
facility: 2nd Dept. of Pediatrics Semmelweis Univ.
city: Padova
country: Italy
facility: Associazione Italiana di Ematologia ed Oncologia Pediatrica
city: Amsterdam
country: Netherlands
facility: Emma Children's Hospital
city: Wroclaw
country: Poland
facility: Rectorat of Medical University
city: Valencia
country: Spain
facility: Sociedad Española de Hematología y Oncología Pediátricas
city: Birmingham
country: United Kingdom
facility: University of Birmingham
Study officials:
affiliation: Institut Gustave Roussy, Villejuif, FRANCE
name: Catherine PATTE, MD
role: STUDY_CHAIR
affiliation: Children's Oncology Group, USA
name: Thomas GROSS, MD
role: STUDY_CHAIR
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.