Observational Study of Low Dose FCR in Elderly/Comorbid CLL/SLL: The Q-lite Project
Observational Study of Low Dose FCR in Elderly/Comorbid CLL/SLL: The Q-lite Project
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.
The objective of this observational study is to provide additional data to confirm the safety
 profile and efficacy of low dose FCR for CLL patients treated in clinical practice.

 Specific data of interest are: comorbid concitions, concomitant medication, CLL
 characteristics, prior treatment regimens, adverse events, reasons for discontinuation low
 dose FCR, overal response rates, complete response rate, progression-free survival, overall
 survival.

 This is an observational, non-interventional, medical record review study in CLL patients. A
 total of 200 patients with CLL who have been previously treated with low dose FCR will be
 eligible for the study.
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