Chronic lymphocytic leukemia (CLL)
Conditions
Interventions
Trade Name: MabThera 100 mg Konzentrat zur Herstellung einer Infusionslösung
Product Code: RO 45-2294
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentr
Sponsors
Roche Austria GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • B-CLL (as determined by CD23+, CD5+, CD19+, CD20+) • Treatment indication as defined by the NCI Workshop criteria (see append 5 and Ref 10) • Age =18 • ECOG performance status 0-2 • No previous treatment of the CLL by chemotherapy, radiotherapy or immunotherapy • Life expectancy > 6 months • Patient's written informed consent • Patient using a reliable means of contraception (e.g. physical barrier, contraceptive pill or patch, spermicide and barrier, or IUD) for the duration of the treatment including 2 months thereafter 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
Exclusion criteria
Exclusion criteria: • Active bacterial, viral or fungal infection • Positivity for HIV, Hepatitis B or C • positive Coombs Test and/or autoimmune hemolytic anemia • reduced organ functions and bone marrow dysfunction not due to CLL • creatinine clearance of below 30 ml/min (calculation of crea. clearance: appendix 6) • Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent. • Patients with medical co-morbid conditions that would require long term use (> 1 month) of systemic corticosteroids during study treatment • Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina • Other known co-morbidity with the potential to dominate survival • Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL) • Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the applied drugs • Pregnant or breast feeding women • Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to determine the clinical rate of complete remissions (CR) of the regimen [Induction treatment with 3 cycles of R-FC, then three cycles of R-F. Patients in CR or PRcontinue with R maintenance therapy (1 infusion every three months) for two years.]. The best response at any point of treatment/maintenance will be determined. ;Secondary Objective: • CR, PRand nPR rate after 3 courses of induction; after 6 courses of induction; and during Rituximab maintenance • Time to next treatment • Molecular CR after 3 courses of induction; after 6 courses of induction; and during Rituximab maintenance • overall toxicity of the regimen (all grades • Cytogenetic risk profile and sensitivity to the regimen • Molecular risk profile as determined by microarray RNA analysis • mutational status of IgVH genes via ZAP-70 expression detection ;Primary end point(s): The primary objective of this study is to determine the clinical rate of complete remissions (CR) of the regimen. The best response at any point of treatment/maintenance will be determined. | — |
Countries
Austria
Outcome results
None listed