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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Collaborator:
Children's Oncology Group
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01516567
First received: January 19, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Primary Mediastinal Large B Cell Lymphoma
Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Event free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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:
  • Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival

  • Acute toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Acute toxicity during treatment according to NCI-CTC V4

  • Long term toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Long term toxicity, especially immune reconstitution, cardiac toxicity


Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516567

Contacts
Contact: Catherine PATTE, MD 33 1 42 11 41 76 catherine.patte@igr.fr
Contact: Thomas GROSS, MD thomas.gross@nationwidechildrens.org

Locations
Belgium
University Hospitals Leuven Active, not recruiting
Leuven, Belgium, 3000
France
Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Catherine Patte, MD    0142114176 ext +33    catherine.patte@igr.fr   
Contact: Anne Tulard    0142116636 ext +33    anne.tulard@gustaveroussy.fr   
Principal Investigator: Catherine Patte, MD         
Hungary
2nd Dept. of Pediatrics Semmelweis Univ. Active, not recruiting
Budapest, Hungary, 1094
Italy
Associazione Italiana di Ematologia ed Oncologia Pediatrica Recruiting
Padova, Italy, 35128
Contact: Angelo Roselo, MD    + 39 049 821 3579    angelo.rosolen@unipd.it   
Principal Investigator: Angelo Roselo, MD         
Netherlands
Emma Children's Hospital Active, not recruiting
Amsterdam, Netherlands, 1105 AZ
Spain
Sociedad Española de Hematología y Oncología Pediátricas Active, not recruiting
Valencia, Spain, 46010
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Children's Oncology Group
Investigators
Study Chair: Catherine PATTE, MD Institut Gustave Roussy, Villejuif, FRANCE
Study Chair: Thomas GROSS, MD Children's Oncology Group, USA
  More Information

Additional Information:
No publications provided

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01516567     History of Changes
Other Study ID Numbers: Inter B-NHL Ritux 2010 Phase 2, 2010-019224-31
Study First Received: January 19, 2012
Last Updated: November 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Doxorubicin
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on July 23, 2014