Observational Study of Low Dose FCR in Elderly/Comorbid CLL/SLL: The Q-lite Project
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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:
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Outcome Measures
Primary Outcome Measures
- Toxicity [8 months]
Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.)
Secondary Outcome Measures
- Overall response rate [8 months]
- Complete response rate [8 months]
- Progression-free survival [3 years]
- Overall survival [3 years]
- Quality of life [3 years]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Hematology - Oncology, University Hospital | Brno | Czech Republic | 60500 | |
| 2 | Department of Hemato-Oncology, University Hospital | Olomouc | Czech Republic | 77520 | |
| 3 | Department of Hematology, University Hospital | Plzen | Czech Republic | 30599 | |
| 4 | Department of Medicine - Hematology, University Hospital Kralovske Vinohrady | Praha | Czech Republic | 10034 | |
| 5 | 1st Department of Medicine - Hematology, University General Hospital | Praha | Czech Republic | 12808 | |
| 6 | Institute for Hematology and Blood Transfusion | Praha | Czech Republic | 12820 | |
| 7 | 4th Department of Medicine - Hematology, University Hospital | Hradec Kralove | ČR | Czech Republic | 50005 |
Sponsors and Collaborators
- Czech CLL Study Group
Investigators
- Study Chair: Lukáš Smolej, M.D. Ph.D., Czech CLL Study Group
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Q-lite