Chronic Lymphocytic Leukemia Clinical Trial
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
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.
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Observational Model: Cohort, Time Perspective: Retrospective
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