Overview
Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2021-12-01
2021-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Oncology Group
Gustave Roussy, Cancer Campus, Grand ParisCollaborators:
Children's Oncology Group
National Cancer Institute (NCI)Treatments:
Calcium, Dietary
Cortisol succinate
Cyclophosphamide
Cytarabine
Doxorubicin
Etoposide
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Leucovorin
Levoleucovorin
Liposomal doxorubicin
Methotrexate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Rituximab
Vincristine
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.