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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Low dose FCR in Elderly/Comorbid CLL

low dose FCR

low-dose FCR

Intervention Type DRUG

FCR with attenuated dose of fludarabine and cyclophosphamide

Interventions

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low-dose FCR

FCR with attenuated dose of fludarabine and cyclophosphamide

Intervention Type DRUG

Other Intervention Names

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Fludarabine Cyclophosphamide Rituximab

Eligibility Criteria

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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