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

January 19, 2012
November 25, 2013
December 2011
June 2019   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01516567 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Mediastinal Large B Cell Lymphoma
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.
Experimental: DA-EPOCH-R
6 courses of Dose Adjusted-EPOCH-Rituximab
Intervention: Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2021
June 2019   (final data collection date for primary outcome measure)

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.
Both
6 Months to 17 Years
No
Contact: Catherine PATTE, MD 33 1 42 11 41 76 catherine.patte@igr.fr
Contact: Thomas GROSS, MD thomas.gross@nationwidechildrens.org
Belgium,   France,   Hungary,   Italy,   Netherlands,   Spain
 
NCT01516567
Inter B-NHL Ritux 2010 Phase 2, 2010-019224-31
Yes
Gustave Roussy, Cancer Campus, Grand Paris
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
Gustave Roussy, Cancer Campus, Grand Paris
November 2013

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