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

A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA0 个研究点目标入组 40 人开始时间: 2012年6月19日最近更新: 2014年1月27日

适应症

试验速览

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•- 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 5
•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

•HISTOLOGY AND STAGING DISEASE - 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. GENERAL CONDITIONS - 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. PRIOR THERAPY - Past or current anti-cancer treatment except corticosteroids during less than one week. EXCLUSION CRITERIA RELATED TO RITUXIMAB: - 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.

发起方

A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA