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

Gustave Roussy

Status and phase

Unknown

Phase 2

Conditions

Primary Mediastinal Large B Cell Lymphoma

Treatments

Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT01516567

2010-019224-31 (EudraCT Number)

Inter B-NHL Ritux 2010 Phase 2

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

6 months to 17 years old

Volunteers

No Healthy Volunteers

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.