- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156726
Observational Study of Low Dose FCR in Elderly/Comorbid CLL/SLL: The Q-lite Project (Q-lite)
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
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Brno, Czech Republic, 60500
- Department of Hematology - Oncology, University Hospital
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Olomouc, Czech Republic, 77520
- Department of Hemato-Oncology, University Hospital
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Plzen, Czech Republic, 30599
- Department of Hematology, University Hospital
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Praha, Czech Republic, 10034
- Department of Medicine - Hematology, University Hospital Kralovske Vinohrady
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Praha, Czech Republic, 12808
- 1st Department of Medicine - Hematology, University General Hospital
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Praha, Czech Republic, 12820
- Institute for Hematology and Blood Transfusion
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ČR
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Hradec Kralove, ČR, Czech Republic, 50005
- 4th Department of Medicine - Hematology, University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Low dose FCR in Elderly/Comorbid CLL
low dose FCR
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FCR with attenuated dose of fludarabine and cyclophosphamide
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity
Time Frame: 8 months
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Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.)
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8 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 3 years
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3 years
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Progression-free survival
Time Frame: 3 years
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3 years
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Overall response rate
Time Frame: 8 months
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8 months
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Complete response rate
Time Frame: 8 months
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8 months
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Quality of life
Time Frame: 3 years
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lukáš Smolej, M.D. Ph.D., Czech CLL Study Group
Publications and helpful links
General Publications
- Smolej L. Therapy of elderly/comorbid patients with chronic lymphocytic leukemia. Curr Pharm Des. 2012;18(23):3399-405. doi: 10.2174/138161212801227096.
- Smolej L, Brychtova Y, Cmunt E, Doubek M, Spacek M, Belada D, Simkovic M, Stejskal L, Zygulova I, Urbanova R, Brejcha M, Zuchnicka J, Mocikova H, Kozak T; Czech CLL Study Group. Low-dose fludarabine and cyclophosphamide combined with rituximab in the first-line treatment of elderly/comorbid patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL): long-term results of project Q-lite by the Czech CLL Study Group. Br J Haematol. 2021 May;193(4):769-778. doi: 10.1111/bjh.17373. Epub 2021 Feb 22.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
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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