OFOCIR
ACTRN12608000404325
Treatment
Phase 2
Commercial sector/Industry,Roche
Prof Stephen Mulligan
The trial is a randomised phase II open-label multicentre trial investigating oral fludarabine, cyclophosphamide and intravenous rituximab in previously untreated elderly (= 65 years old) patients with chronic lymphocytic leukaemia. The primary objective is to investigate the tolerability of each of three of these combination chemotherapies and the associated primary endpoint is the proportion of paitens able to complete 6 cycles of therapy.
1. B-CLL confirmed according to National Cancer Institute (NCI) Working Group Criteria. 2. Binet stage B or C, or progressive symptomatic stage A (see Protocol Appendix I). 3. Age = 65 years old. 4. Judged to be in need of systemic therapy (see Protocol Appendix II). 5. No previous treatment (chemotherapy, radiotherapy or immunotherapy) for CLL. 6. Alkaline phosphatase and transaminases = 2 x ULN.(Upper Limits of Normal) 7. Creatinine clearance = 50 ml/min (as calculated by (estimated Glomerular .... Read more
1. Age < 65 years old. 2. Non-progressive or stable Binet stage A. 3. Clinically significant auto-immune cytopenia, Coombs-positive haemolytic anaemia (as discerned by treating physician). 4. Active second malignancy currently requiring treatment (except for non-melanoma skin cancer or cervical cancer in situ or tumour treated curatively by surgery > 5 years ago) 5. Concomitant disease requiring prolonged use of glucocorticoids (> 1 month). 6. Known hypersensitivity with anaphylactic reaction to .... Read more
No
Sample Size 120
Min. age 65 Years
Max. age 0 No limit
Sex Both males and females
Condition category Chronic Lymphocytic Leukaemia (CLL)
Condition code Cancer
Intervention code Treatment: Drugs
To investigate the safety and tolerability of fludarabine, cyclophosphamide, and rituximab in previously untreated elderly (=65years old) patients with chronic lymphocytic leukaemia. (CLL). Treatment Arm1:oral fludarabine 24 mg/m2 days 1-5. plus intravenous (i.v.) rituximab Cycle 1: 375 mg/m2 day 0* Cycles 2-6: 500 mg/m2 day 1 (Fludarabine Rituximab:FR5), Treatment Arm2 and Arm3 :oral fludarabine 24 mg/m2 days 1-3. plus oral cyclophosphamide 150 mg/m2 days 1-3. in varing dose intensity with i.v. .... Read more
Control group Dose comparison
'There are three cohorts of active treatment. Randomisation arms allocated via randomisation (as described in the description of the interventions)'.
Outcome: The proportion of patients completing 6 treatment cyclesTimepoint: 24 weeks (6 x 28 day cycles)
yes
De-identified IPD data, for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Assessed on a case-by-case basis