Primary Mediastinal Large B Cell Lymphoma
Conditions
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.
Interventions
DRUGEtoposide, 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.
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Children's Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event free survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 5 years | Overall survival |
| Acute toxicity | 6 months | Acute toxicity during treatment according to NCI-CTC V4 |
| Long term toxicity | 5 years | Long term toxicity, especially immune reconstitution, cardiac toxicity |
Countries
Belgium, Canada, France, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom
Contacts
STUDY_CHAIRCatherine PATTE, MD
Institut Gustave Roussy, Villejuif, FRANCE
STUDY_CHAIRThomas GROSS, MD
Children's Oncology Group, USA
Outcome results
None listed