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

Phase 2

• Conditions: Primary Mediastinal Large B Cell Lymphoma
• Interventions: Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab

• Registration Number: NCT01516567
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Study Start: 2012-04-01
• Primary Completion: 2017-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DA-EPOCH-R	Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab	6 courses of Dose Adjusted-EPOCH-Rituximab

Primary Outcome Measures

Name	Time	Method
Event free survival	36 months	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.

Secondary Outcome Measures

Name	Time	Method
Survival	5 years	Overall survival
Long term toxicity	5 years	Long term toxicity, especially immune reconstitution, cardiac toxicity
Acute toxicity	6 months	Acute toxicity during treatment according to NCI-CTC V4

Trial Locations

Locations (9)

Associazione Italiana di Ematologia ed Oncologia Pediatrica; 🇮🇹 Padova, Italy

Children Oncology Group Operations centres; 🇨🇦 Monrovia, Canada

2nd Dept. of Pediatrics Semmelweis Univ.; 🇭🇺 Budapest, Hungary

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Gustave Roussy; 🇫🇷 Villejuif, France

Emma Children's Hospital; 🇳🇱 Amsterdam, Netherlands

Rectorat of Medical University; 🇵🇱 Wroclaw, Poland

Sociedad Española de Hematología y Oncología Pediátricas; 🇪🇸 Valencia, Spain

University of Birmingham; 🇬🇧 Birmingham, United Kingdom