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Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
Conditions
Primary Mediastinal Large B Cell Lymphoma
Conditions: official terms
Lymphoma, B-Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
Type: Drug
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: 17 Years
Minimum Age: 6 Months
Gender: Both
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.
- 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.
Locations
University Hospitals Leuven
Leuven, Belgium
Gustave Roussy
Status: Active, not recruiting
Villejuif, France
2nd Dept. of Pediatrics Semmelweis Univ.
Status: Recruiting
Contact: Véronique Minard, MD - 0142114211 - veronique.minard@gustaveroussy.fr
Budapest, Hungary
Associazione Italiana di Ematologia ed Oncologia Pediatrica
Status: Active, not recruiting
Padova, Italy
Emma Children's Hospital
Status: Active, not recruiting
Amsterdam, Netherlands
Rectorat of Medical University
Status: Active, not recruiting
Wroclaw, Poland
Sociedad Española de Hematología y Oncología Pediátricas
Status: Not yet recruiting
Contact: Bernarda Kazanowska, MD-PhD - 717703169 - B.Kazanowska@mypost.pl
Valencia, Spain
University of Birmingham
Status: Active, not recruiting
Birmingham, United Kingdom
Status: Recruiting
Contact: Amos Burke, MD - amos.burke@addenbrookes.nhs.uk
Start Date
December 2011
Completion Date
December 2021
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Source
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page