INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTS WITH B-CELL NHL OR B-AL: EVALUATION OF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS - Inter-B-NHL ritux 2010

Institut Gustave Roussy0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月29日

适应症

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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., OTHERS, -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
•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
•duration 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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