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:
Participant gender:
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.