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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose FCR in Elderly/Comorbid CLL | low dose FCR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose FCR | Drug | FCR with attenuated dose of fludarabine and cyclophosphamide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Toxicity assessed by CTCAE criteria (myelotoxicity, infections, etc.) | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | 8 months | |
| Complete response rate | 8 months | |
| Progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with CLL or SLL deemed unfit for full-dose FCR. Both untreated and relapsed/refractory setting.
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| Name | Affiliation | Role |
|---|---|---|
| Lukáš Smolej, M.D. Ph.D. | Czech CLL Study Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology - Oncology, University Hospital | Brno | 60500 | Czechia | |||
| Department of Hemato-Oncology, University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22591390 | Result | Smolej L. Therapy of elderly/comorbid patients with chronic lymphocytic leukemia. Curr Pharm Des. 2012;18(23):3399-405. doi: 10.2174/138161212801227096. | |
| 33618437 | Derived | 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. |
| Label | URL |
|---|---|
| Czech CLL Study Group | View source |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011961 | Receptors, Fc |
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
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| 3 years |
| Overall survival | 3 years |
| Quality of life | 3 years |
| Olomouc |
| 77520 |
| Czechia |
| Department of Hematology, University Hospital | Pilsen | 30599 | Czechia |
| Department of Medicine - Hematology, University Hospital Kralovske Vinohrady | Prague | 10034 | Czechia |
| 1st Department of Medicine - Hematology, University General Hospital | Prague | 12808 | Czechia |
| Institute for Hematology and Blood Transfusion | Prague | 12820 | Czechia |
| 4th Department of Medicine - Hematology, University Hospital | Hradec Králové | ČR | 50005 | Czechia |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |