Observational Study of Low Dose FCR in Elderly/Comorbid CLL/SLL: The Q-lite Project

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

FCR (fludarabine, cyclophosphamide, rituximab) combination is currently accepted as the gold standard in treatment of younger and physically fit CLL patients. These excellent results, however, cannot be generally applied to the whole CLL population. This is because the median age at diagnosis of CLL lies between 65 and 72 years and patients older than 65 years in fact account up to 50%-75 % of the CLL population. Nevertheless, such population is considerably underrepresented in most of the large clinical trials in CLL/SLL. Therefore, it is not clear whether elderly/comorbid patients could profit from newer treatment approaches such as purine analog combinations or chemoimmunotherapy. Several publications demonstrated unacceptable toxicity of full-dose FC/FCR in elderly CLL patients. However, regimens using attenuated doses of fludarabine and cyclophosphamide showed promising efficacy and low toxicity.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Czech CLL Study Group
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab

Criteria

Inclusion Criteria:

• confirmed diagnosis of CLL or SLL

• previously treated by low dose FCR for active disease requiring treatment per IWCLL criteria

• dose reduction of fludarabine and cyclophosphamide due to age, comorbid conditions, or reduce creatinine clearance

Exclusion Criteria:

• patients treated with low dose FCR within prospective clinical trials