Single-agent rituximab as maintenance treatment versus observation after combined induction immunochemotherapy with fludarabine, cyclophosphamide and rituximab (FCR) in patients older than 65 years with previously untreated B-cell chronic lymphocytic leukemia (B-CLL): a phase III intergroup trial of the GOELAMS and the FCGCLL/WM groups. - LLC 2007 SA

CHU TOURS0 个研究点目标入组 304 人开始时间: 2007年6月27日最近更新: 2019年12月10日

试验速览

暂无简介。

•Inclusion criteria
•Matutes score : 4 or 5
•Binet stages B and C
•Age > 65 years old
•No previous treatment of CLL by chemotherapy, radiotherapy or immunotherapy, except glucocorticoids < 1 month
•Patient’s written informed consent
•Life expectancy > 6 months
•Inclusion criteria at randomization
•Patients having received the full induction phase with 4 FC and 6 rituximab courses (with/without dose adjustments as per protocol)
•Complete or partial response according to NCI criteria at the end of induction phase
•Recovery from FCR toxicities
•Patient willingness to continue on protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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) yes
•F.1.3.1 Number of subjects for this age range

•ECOG PS 2 to 4
•Presence of 17 deletion by FISH
•Clinically significany auto-immune cytopenia
•History of another malignancy in CR less than 5 years, except basal cell skin cancer or tumor treated curatively by surgery
•Any severe co-morbidities of heart, pulmonary function
•Known hypersensitivity to murine proteins or to any of the study drugs or their components
•Transformation into an aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma, or prolymphocytic leukemia)
•Active bacterial, viral or fungal infection
•Seropositivity HIV, hepatitis C or hepatitis B (unless clearly due to vaccination)
•Total bilirubin, alkaline phosphatases and aminotransferases > 2 x ULN
•Creatinine clearance < 60 ml/min calculated according to the formula of Cockcroft and Gault
•Any coexisting medical or psychological condition that would preclude participation to the required study procedures
•Patient with mental deficiency preventing proper understanding of the requirements of treatment

发起方

CHU TOURS