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

Chronic Lymphocytic Leukemia Clinical Trial

— Q-lite  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02156726
• Other study ID #: Q-lite
• Status: Active, not recruiting
• Phase: N/A
• First received: May 24, 2014
• Last updated: June 3, 2014
• Start date: March 2011
• Est. completion date: July 2015

Study information

• Verified date: May 2014
• Source: Czech CLL Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Statni ustav pro kontrolu leciv
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• low-dose FCR
FCR with attenuated dose of fludarabine and cyclophosphamide

Locations

Country	Name	City	State
Czech Republic	Department of Hematology - Oncology, University Hospital	Brno
Czech Republic	4th Department of Medicine - Hematology, University Hospital	Hradec Kralove	CR
Czech Republic	Department of Hemato-Oncology, University Hospital	Olomouc
Czech Republic	Department of Hematology, University Hospital	Plzen
Czech Republic	1st Department of Medicine - Hematology, University General Hospital	Praha
Czech Republic	Department of Medicine - Hematology, University Hospital Kralovske Vinohrady	Praha
Czech Republic	Institute for Hematology and Blood Transfusion	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Czech CLL Study Group

Country where clinical trial is conducted

Czech Republic, 

References & Publications (1)

Smolej L. Therapy of elderly/comorbid patients with chronic lymphocytic leukemia. Curr Pharm Des. 2012;18(23):3399-405. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity	Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.)	8 months	Yes
Secondary	Overall response rate		8 months	No
Secondary	Complete response rate		8 months	No
Secondary	Progression-free survival		3 years	No
Secondary	Overall survival		3 years	No
Secondary	Quality of life		3 years	No

External Links

•   Czech CLL Study Group