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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01516567
Recruitment Status : Unknown
Verified August 2017 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Children's Oncology Group
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE January 19, 2012
First Posted Date  ICMJE January 25, 2012
Last Update Posted Date August 2, 2017
Actual Study Start Date  ICMJE December 1, 2011
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01516567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2012)
  • Survival [ Time Frame: 5 years ]
    Overall survival
  • Acute toxicity [ Time Frame: 6 months ]
    Acute toxicity during treatment according to NCI-CTC V4
  • Long term toxicity [ Time Frame: 5 years ]
    Long term toxicity, especially immune reconstitution, cardiac toxicity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Mediastinal Large B Cell Lymphoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: DA-EPOCH-R
6 courses of Dose Adjusted-EPOCH-Rituximab
Intervention: Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 28, 2015)
47
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2012)
40
Estimated Study Completion Date  ICMJE April 2019
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Hungary,   Italy,   Netherlands,   Poland,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01516567
Other Study ID Numbers  ICMJE Inter B-NHL Ritux 2010 Phase 2
2010-019224-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE Children's Oncology Group
Investigators  ICMJE
Study Chair: Catherine PATTE, MD Institut Gustave Roussy, Villejuif, FRANCE
Study Chair: Thomas GROSS, MD Children's Oncology Group, USA
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP