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Trial Title:
Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
NCT ID:
NCT01516567
Condition:
Primary Mediastinal Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Cyclophosphamide
Rituximab
Doxorubicin
Etoposide
Vincristine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
Description:
6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at
each of the 6 courses of EPOCH.
Arm group label:
DA-EPOCH-R
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
6 Months
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Facility:
Name:
Children Oncology Group Operations centres
Address:
City:
Monrovia
Country:
Canada
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Facility:
Name:
2nd Dept. of Pediatrics Semmelweis Univ.
Address:
City:
Budapest
Zip:
1094
Country:
Hungary
Facility:
Name:
Associazione Italiana di Ematologia ed Oncologia Pediatrica
Address:
City:
Padova
Zip:
35128
Country:
Italy
Facility:
Name:
Emma Children's Hospital
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Facility:
Name:
Rectorat of Medical University
Address:
City:
Wroclaw
Country:
Poland
Facility:
Name:
Sociedad Española de Hematología y Oncología Pediátricas
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Facility:
Name:
University of Birmingham
Address:
City:
Birmingham
Country:
United Kingdom
Start date:
April 1, 2012
Completion date:
December 2021
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Collaborator:
Agency:
Children's Oncology Group
Agency class:
Other
Source:
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01516567
http://www.igr.fr
