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

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ClinicalTrials.gov Identifier: NCT01516567
Recruitment Status : Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : August 2, 2017
Children's Oncology Group
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Primary Mediastinal Large B Cell Lymphoma Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : December 1, 2011
Primary Completion Date : April 2016
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Event free survival [ Time Frame: 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 [ Time Frame: 5 years ]
    Overall survival

  2. Acute toxicity [ Time Frame: 6 months ]
    Acute toxicity during treatment according to NCI-CTC V4

  3. Long term toxicity [ Time Frame: 5 years ]
    Long term toxicity, especially immune reconstitution, cardiac toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516567

University Hospitals Leuven
Leuven, Belgium, 3000
Children Oncology Group Operations centres
Monrovia, Canada
Gustave Roussy
Villejuif, France, 94805
2nd Dept. of Pediatrics Semmelweis Univ.
Budapest, Hungary, 1094
Associazione Italiana di Ematologia ed Oncologia Pediatrica
Padova, Italy, 35128
Emma Children's Hospital
Amsterdam, Netherlands, 1105 AZ
Rectorat of Medical University
Wroclaw, Poland
Sociedad Española de Hematología y Oncología Pediátricas
Valencia, Spain, 46010
United Kingdom
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

Additional Information:
Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01516567     History of Changes
Obsolete Identifiers: NCT01595048
Other Study ID Numbers: Inter B-NHL Ritux 2010 Phase 2
2010-019224-31 ( EudraCT Number )
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents