Prospective Randomized Trial of Immediate Treatment with Campath versus Deferred Therapy in Patients with Previously Untreated Binet Stage A B-Cell Chronic Lymphocytic Leukemia at High Risk for Disease Progression - ND

G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI0 个研究点开始时间: 2007年3月9日最近更新: 2012年3月19日

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•Previously untreated male and female patients with Binet stage A CLL who do not necessitate therapy, according to NCI criteria and newly diagnosed not more than 12 months before registration . 7.1 Inclusion Criteria 1 Established diagnosis of B-CLL by NCI criteria, performed by local haematologist. Diagnosis will be confirmed by the biological review committee according to flow cytometry analysis CD5 /CD19 /CD23 . 2 Age 18 years and 70 years 3 Binet stage A Appendix B 4 Diagnosis performed within 12 months before inclusion in the study 5 All patients with Binet stage A disease who do not necessitate therapy by NCI criteria guidelines should be included 6 Patients at high risk of disease progression for the presence of 2 or more of the following risk factors a CD38 30 b Zap-70 strong at Western Blot analysis c IgVH status unmutated degree of homology 2 7 ECOG performance status 0 2 Appendix C 8 ...................
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1 Patients with CLL whose diagnosis exceed 12 months before inclusion in the study 2 Age 70 and 18 years 3 ECOG performance status 2 4 Patients with leukemic phase of lymphoproliferative disorders of B-cell origin CD5- and/or CD23- according to flow cytometry analysis 5 Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease 6 Medical condition requiring the prolonged estimated to be more than one month use of oral corticosteroids 7 History of anaphylactic reaction following exposure to humanized monoclonal antibodies 8 Patients with active bacterial, viral or fungal infection 9 HIV positivity, HBV and HBC positivity assessed by DNA copies 10 CMV status as evaluated by pathological values detected by CMV specific quantitative 11 ............

发起方

G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI