Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group; Gustave Roussy, Cancer Campus, Grand Paris
• Collaborators: 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.