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

June 3, 2014 updated by: Czech CLL Study Group

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 60500
        • Department of Hematology - Oncology, University Hospital
      • Olomouc, Czech Republic, 77520
        • Department of Hemato-Oncology, University Hospital
      • Plzen, Czech Republic, 30599
        • Department of Hematology, University Hospital
      • Praha, Czech Republic, 10034
        • Department of Medicine - Hematology, University Hospital Kralovske Vinohrady
      • Praha, Czech Republic, 12808
        • 1st Department of Medicine - Hematology, University General Hospital
      • Praha, Czech Republic, 12820
        • Institute for Hematology and Blood Transfusion
    • ČR
      • Hradec Kralove, ČR, Czech Republic, 50005
        • 4th Department of Medicine - Hematology, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with CLL or SLL deemed unfit for full-dose FCR. Both untreated and relapsed/refractory setting.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low dose FCR in Elderly/Comorbid CLL
low dose FCR
Drug: low-dose FCR
FCR with attenuated dose of fludarabine and cyclophosphamide
Other Names:
  • Rituximab
  • Cyclophosphamide
  • Fludarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity
Time Frame: 8 months
Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.)
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
Progression-free survival
Time Frame: 3 years
3 years
Overall response rate
Time Frame: 8 months
8 months
Complete response rate
Time Frame: 8 months
8 months
Quality of life
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech CLL Study Group

Investigators

  • Study Chair: Lukáš Smolej, M.D. Ph.D., Czech CLL Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

May 24, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q-lite

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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