INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTSWITH B-CELL NHL OR B-AL: EVALUATIONOF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS - Inter-B-NHL ritux 2010

Institut Gustave Roussy0 个研究点目标入组 529 人开始时间: 2011年11月30日最近更新: 2023年10月23日

试验速览

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•HISTOLOGY AND STAGING DISEASE
•Phase III study:
•-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.
•Phase II study:
•-Histolo-cytologically proven PMLBL.
•-PMLBL without CNS involvement.
•GENERAL CONDITIONS
•-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.
•INITIAL WORK-UP
•-Complete initial work-up within 8 days prior to treatment.
•-Able to comply with scheduled follow-up and with management of toxicity.
•-Signed informed consent from patients and/or their parents or legal guardians.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 529
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study.
•-In phase II study (PMLBL) patients with CNS involvement are not eligible.
•-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 of less than 7 days deviation in total.
•-Tumor cell negative for CD20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria)
•-Prior exposure to rituximab.
•-Severe active viral infection, especially hepatitis B. Severe infection (such as sepsis, pneumonia, etc..) should be clinically controlled at the time of randomisation. Contact the national co-investigator for further advice if necessary.
•- Hepatitis B carrier status history of HBV or positive serology

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