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

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: low-dose FCR

• Registration Number: NCT02156726
• Lead Sponsor: Czech CLL Study Group

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-03
• Status Verified: 2014-05
• Study First Submitted: 2014-05-24
• Study First Submitted QC: 2014-06-03
• Last Update Submitted: 2014-06-03
• Study First Posted: 2014-06-05
• Last Update Posted: 2014-06-05
• Primary Completion: 2014-10
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low dose FCR in Elderly/Comorbid CLL	low-dose FCR	low dose FCR

Primary Outcome Measures

Name	Time	Method
Toxicity	8 months	Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	3 years
Complete response rate	8 months
Quality of life	3 years
Overall response rate	8 months
Overall survival	3 years

Trial Locations

Locations (7)

Department of Medicine - Hematology, University Hospital Kralovske Vinohrady; 🇨🇿 Praha, Czech Republic

4th Department of Medicine - Hematology, University Hospital; 🇨🇿 Hradec Kralove, ČR, Czech Republic

Department of Hematology, University Hospital; 🇨🇿 Plzen, Czech Republic

Department of Hematology - Oncology, University Hospital; 🇨🇿 Brno, Czech Republic

Department of Hemato-Oncology, University Hospital; 🇨🇿 Olomouc, Czech Republic

1st Department of Medicine - Hematology, University General Hospital; 🇨🇿 Praha, Czech Republic

Institute for Hematology and Blood Transfusion; 🇨🇿 Praha, Czech Republic