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 3

Completed

• Conditions: Chronic lymphocytic leukaemia (CLL); Cancer; Leukaemia

• Registration Number: ISRCTN02757147
• Lead Sponsor: German CLL Study Group - GCLLSG (Germany)

Brief Summary

2010 Results article in https://pubmed.ncbi.nlm.nih.gov/20194844/ (added 23/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-12-12
• Study Completion: 2008-09-30
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 552

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

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 <70 ml/min
9. Total bilirubin >2 fold of upper normal limit
10. Total cumulative illness rating scale (CIRS) score >6
11. Cerebral dysfunction, legal incapacity
12. Richter's syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified