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The purpose of this observational study is to provide additional data to confirm the safety profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic leukemia patients with significant comorbidities treated in routine clinical practice.
BR (bendamustine, rituximab) combination is currently accepted as a first-line treatment of chronic lymphocytic leukemia (CLL) in patients for whom fludarabine combination chemotherapy is not appropriate.
The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of BR for CLL patients treated in routine clinical practice.
Specific data of interest are: comorbid conditions, CLL characteristics, adverse events, reasons for discontinuation BR, overall response rates, complete response rate, progression-free survival, overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR in CLL | Patients receive bendamustine hydrochloride 90mg/m2 IV on days 1 and 2 each cycle. Patients also receive rituximab 375 mg/m2 IV on day 1 at first cycle and 500 mg/m2 on day 1 all subsequent cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine and Rituximab | Drug | Patients receive bendamustine and rituximab. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria | Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria (myelotoxicity, infections, etc.) | 8 months |
| Overall response rate | Response to treatment was assessed using National Cancer Institute-sponsored Working Group criteria, including bone marrow examination and radiographic confirmation of complete response. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Calculated from the start of therapy until disease progression or death | 3 years |
| Overall survival | Time interval from the start of therapy until death form any cause |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic lymphocytic leukemia.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Spacek, MD, PhD | Czech CLL Study Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology - Oncology, University Hospital | Brno | 60500 | Czechia | |||
| 4th Department of Medicine - Hematology, University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22869884 | Background | Fischer K, Cramer P, Busch R, Bottcher S, Bahlo J, Schubert J, Pfluger KH, Schott S, Goede V, Isfort S, von Tresckow J, Fink AM, Buhler A, Winkler D, Kreuzer KA, Staib P, Ritgen M, Kneba M, Dohner H, Eichhorst BF, Hallek M, Stilgenbauer S, Wendtner CM. Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2012 Sep 10;30(26):3209-16. doi: 10.1200/JCO.2011.39.2688. Epub 2012 Aug 6. | |
| Result | Obrtlikova P, Spacek M, Doubek M, Hadrabova M, Panovska A, Svackova K, Trneny M. Bendamustine with rituximab (BR) is safe treatment option with high response rate for chronic lymphocytic leukemia in elderly patients with comorbidities. LEUKEMIA & LYMPHOMA 56(1SI): 151-153, 2015 [abstract #180]. | ||
| Result | Spacek M, Obrtlikova P, Hadrabova M, Cmunt E, Karban J, Molinsky J, Simkovic M, Mocikova H, Mohammadova L, Panovska A, Novak J, Smolej L, Doubek M, Trneny M. Observational study in comorbid patients with CLL receiving first-line rituximab-bendamustine. XVII International Workshop on CLL, New York, May 12-15, 2017 [abstract #148] |
| 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 |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 3 years |
| Hradec Králové |
| 50005 |
| 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, General University Hospital | Prague | 12808 | Czechia |
| 30797139 | Derived | Spacek M, Obrtlikova P, Hrobkova S, Cmunt E, Karban J, Molinsky J, Simkovic M, Mocikova H, Mohammadova L, Panovska A, Novak J, Trneny M, Smolej L, Doubek M. Prospective observational study in comorbid patients with chronic lymphocytic leukemia receiving first-line bendamustine with rituximab. Leuk Res. 2019 Apr;79:17-21. doi: 10.1016/j.leukres.2019.02.002. Epub 2019 Feb 15. |
| 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 |
| D009588 |
| Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |