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

Gustave Roussy, Cancer Campus, Grand Paris (Other)
Overall Status
Active, not recruiting ID
Children's Oncology Group (Other)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
Phase 2

Study Design

Study Type:
Actual Enrollment :
47 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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
Actual Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Apr 1, 2017
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: DA-EPOCH-R

6 courses of Dose Adjusted-EPOCH-Rituximab

Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Survival [5 years]

    Overall survival

  2. Acute toxicity [6 months]

    Acute toxicity during treatment according to NCI-CTC V4

  3. Long term toxicity [5 years]

    Long term toxicity, especially immune reconstitution, cardiac toxicity

Eligibility Criteria


Ages Eligible for Study:
6 Months to 17 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 University Hospitals Leuven Leuven Belgium 3000
2 Children Oncology Group Operations centres Monrovia Canada
3 Gustave Roussy Villejuif France 94805
4 2nd Dept. of Pediatrics Semmelweis Univ. Budapest Hungary 1094
5 Associazione Italiana di Ematologia ed Oncologia Pediatrica Padova Italy 35128
6 Emma Children's Hospital Amsterdam Netherlands 1105 AZ
7 Rectorat of Medical University Wroclaw Poland
8 Sociedad Española de Hematología y Oncología Pediátricas Valencia Spain 46010
9 University of Birmingham Birmingham United Kingdom

Sponsors and Collaborators

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


  • Study Chair: Catherine PATTE, MD, Institut Gustave Roussy, Villejuif, FRANCE
  • Study Chair: Thomas GROSS, MD, Children's Oncology Group, USA

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
Other Study ID Numbers:
  • Inter B-NHL Ritux 2010 Phase 2
  • 2010-019224-31
  • NCT01595048
First Posted:
Jan 25, 2012
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 2021

Study Results

No Results Posted as of Mar 18, 2021