The trial compares single-agent rituximab as maintenance treatment versus observation after combined immunochematherapy with fludarabine, cyclophosphamide and rituximab (FCR) in patients older than 65 years with previously B-cell chronic lymphocytic leukemia. MedDRA version: 9.1 Level: LLT Classification code 10009310 Term: CLL
Conditions
Interventions
Trade Name: IMP1 MabThera (rituximab)
Product Name: rituximab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: rituximab
Sponsors
CHU TOURS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • B-CLL • 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 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
Exclusion criteria
Exclusion criteria: • 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 • CIRS > 6 • 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 •
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: to demonstrate superiority in 3-year progression-free survival from randomization (PFS) of rituximab maintenance over observation in patients in CR or PR after induction by FCR;Secondary Objective: Secondary: Determine overall response rate (CR and PR) after induction therapy, rates of phenotypic responses, duration of phenotypic, clinical responses, response rates and time-related parameters in biological subgroups, adverse events, CD4/CD8 counts, immunoglobulin levels, incidence of Coombs-positive haemolytic anemiae, pharmacokinetics of rituximab, prognostic impact of the Fc?RIII? genotype, quality of life (QoL), pharmacoeconomics ;Primary end point(s): The objective of this study is to demontrate a clinically relevant statistical superiority in 3-year progression free survival (PFS) from randomization of rituximab maintenance over observation in CR and PR after induction treatment by fludarabine, cyclophosphamide and rituximab. The PFS is defined as the time elapsed between randomization and proressive disease, relapse, death related to B-CLL or initiation of a new treatment. | — |
Countries
France
Outcome results
None listed