This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Treatment low-dose fcr
Sponsor Czech CLL Study Group
Start date March 2011
End date October 2014
Trial size 200 participants
Trial identifier NCT02156726, Q-lite


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
low dose FCR
low-dose fcr Fludarabine
FCR with attenuated dose of fludarabine and cyclophosphamide

Primary Outcomes

time frame: 8 months

Secondary Outcomes

Overall response rate
time frame: 8 months
Complete response rate
time frame: 8 months
Progression-free survival
time frame: 3 years
Overall survival
time frame: 3 years
Quality of life
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Observational Study of Low Dose FCR in the Treatment of Elderly/Comorbid Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma: The Q-lite Project
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Czech CLL Study Group.