Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
NCT ID: NCT01516567
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
47 participants
INTERVENTIONAL
2012-04-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DA-EPOCH-R
6 courses of Dose Adjusted-EPOCH-Rituximab
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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.
* 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.
6 Months
17 Years
ALL
No
Sponsors
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Children's Oncology Group
NETWORK
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Principal Investigators
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Catherine PATTE, MD
Role: STUDY_CHAIR
Institut Gustave Roussy, Villejuif, FRANCE
Thomas GROSS, MD
Role: STUDY_CHAIR
Children's Oncology Group, USA
Locations
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University Hospitals Leuven
Leuven, , Belgium
Children Oncology Group Operations centres
Monrovia, , Canada
Gustave Roussy
Villejuif, , France
2nd Dept. of Pediatrics Semmelweis Univ.
Budapest, , Hungary
Associazione Italiana di Ematologia ed Oncologia Pediatrica
Padua, , Italy
Emma Children's Hospital
Amsterdam, , Netherlands
Rectorat of Medical University
Wroclaw, , Poland
Sociedad Española de Hematología y Oncología Pediátricas
Valencia, , Spain
University of Birmingham
Birmingham, , United Kingdom
Countries
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References
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Burke GAA, Minard-Colin V, Auperin A, Alexander S, Pillon M, Delgado R, Zsiros J, Uyttebroeck A, Dartigues P, Miles RR, Kazanowska B, Chiang AK, Haouy S, Bollard CM, Csoka M, Wheatley K, Barkauskas DA, Adamson PC, Vassal G, Patte C, Gross TG. Dose-Adjusted Etoposide, Doxorubicin, and Cyclophosphamide With Vincristine and Prednisone Plus Rituximab Therapy in Children and Adolescents With Primary Mediastinal B-Cell Lymphoma: A Multicenter Phase II Trial. J Clin Oncol. 2021 Nov 20;39(33):3716-3724. doi: 10.1200/JCO.21.00920. Epub 2021 Sep 27.
Related Links
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Institute Gustave Roussy web site
Other Identifiers
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2010-019224-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Inter B-NHL Ritux 2010 Phase 2
Identifier Type: -
Identifier Source: org_study_id
NCT01595048
Identifier Type: -
Identifier Source: nct_alias
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