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Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia

Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN02757147
Enrollment
760
Registered
2003-12-12
Start date
2003-07-01
Completion date
Unknown
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lymphocytic leukaemia (CLL) Cancer Leukaemia

Interventions

Patients will be randomised between combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) (Arm A) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone (Arm

Sponsors

German CLL Study Group - GCLLSG (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of B-CLL according to National Cancer Institute (NCI)/German CLL Study Group (GCLLSG) criteria 2. Need for treatment 3. Age =18 years 4. Life expectancy >6 months 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 6. Patient's written informed consent 7. Willingness to contraception for the entire duration of the treatment and 2 months thereafter

Exclusion criteria

Exclusion criteria: 1. Manifest autoimmune cytopaenias including Coombs-positive autoimmune haemolytic anaemia 2. Active second malignancy requiring treatment (except basal cell carcinoma or malignant tumour treated curatively by surgery) 3. Prior chemotherapy and/or radiotherapy 4. Pregnancy, nursing 5. Concomitant disease requiring prolonged use of glucocorticoids (>1 month) 6. Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the study drugs 7. Active bacterial, viral or fungal infection 8. Creatinine clearance 2 fold of upper normal limit 10. Total cumulative illness rating scale (CIRS) score >6 11. Cerebral dysfunction, legal incapacity 12. Richter's syndrome

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS)—

Secondary

MeasureTime frame
1. Event-free survival 2. Overall survival 3. Disease-free survival 4. Duration of remission 5. Time to new CLL treatment or death 6. Rates of molecular, complete and partial remission 7. Response rates and survival times in biological subgroups 8. Rates of treatment-related adverse effects 9. Pharmacoeconomic impact 10. Quality of life—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026