Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial
- Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma
or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature
B-cell NHL non other specified or specifiable.
- Stage III with elevated LDH level ("B-high"), [LDH > twice the institutional upper
limit of the adult normal values (> Nx2)] or any stage IV or B-AL.
- 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 and
during five months for men, taking into account the characteristics of methotrexate.
- Complete initial work-up within 8 days prior to treatment that allows definite
- Able to comply with scheduled follow-up and with management of toxicity.
- Signed informed consent from patients and/or their parents or legal guardians
- Follicular lymphoma, MALT and nodular marginal zone are not included into this
- 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
- Tumor cell negative for CD20
- Prior exposure to rituximab.
- Severe active viral infection, especially hepatitis B.
- Hepatitis B carrier status history of 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.