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

NCT01516567 | Completed Phase 2 DMC

• 2 other identifiers: Inter B-NHL Ritux 2010 Phase 22010-019224-31
• Study Type: interventional
• Target: 47
• Locations: 9 countries
• Sites: 9

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.

Conditions

Primary Mediastinal Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Event free survival

  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.

  36 months

Secondary Outcomes (3)

• Survival

  5 years

• Acute toxicity

  6 months

• Long term toxicity

  5 years

Study Arms (1)

DA-EPOCH-R

EXPERIMENTAL

6 courses of Dose Adjusted-EPOCH-Rituximab

Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab

Interventions

Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab DRUG

6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.

DA-EPOCH-R

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Histologically proven Primary Mediastinal Large B-Cell Lymphoma (PMLBL).
• PMLBL without central nervous system (CNS) involvement.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• Children's Oncology Group: collaborator

Study Sites (9)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Children Oncology Group Operations centres

Monrovia, Canada

Location

Gustave Roussy

Villejuif, 94805, France

Location

2nd Dept. of Pediatrics Semmelweis Univ.

Budapest, 1094, Hungary

Location

Associazione Italiana di Ematologia ed Oncologia Pediatrica

Padua, 35128, Italy

Location

Emma Children's Hospital

Amsterdam, 1105 AZ, Netherlands

Location

Rectorat of Medical University

Wroclaw, Poland

Location

Sociedad Española de Hematología y Oncología Pediátricas

Valencia, 46010, Spain

Location

University of Birmingham

Birmingham, United Kingdom

Location

Related Publications (1)

• 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 DERIVED

Related Links

• Institute Gustave Roussy web site

MeSH Terms

Interventions

Etoposide; Doxorubicin; Vincristine; Cyclophosphamide; Rituximab

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Catherine PATTE, MD

  Institut Gustave Roussy, Villejuif, FRANCE

  STUDY CHAIR

• Thomas GROSS, MD

  Children's Oncology Group, USA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 25, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: November 16, 2022
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

BE (1); GB (1); HU (1); IT (1); PL (1); CA (1); ES (1); FR (1); NL (1)