Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
83 participants
OBSERVATIONAL
2014-09-30
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Bendamustine and Rituximab
Patients receive bendamustine and rituximab. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions
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Bendamustine and Rituximab
Patients receive bendamustine and rituximab. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients treated with first-line BR for active disease requiring treatment
* Cumulative Illness Rating Scale (CIRS) \> 6
* Informed consent to data collection
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Czech CLL Study Group
NETWORK
Responsible Party
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Principal Investigators
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Martin Spacek, MD, PhD
Role: STUDY_CHAIR
Czech CLL Study Group
Locations
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Department of Hematology - Oncology, University Hospital
Brno, , Czechia
4th Department of Medicine - Hematology, University Hospital
Hradec Králové, , Czechia
Department of Hematology, University Hospital
Pilsen, , Czechia
Department of Medicine - Hematology, University Hospital Kralovske Vinohrady
Prague, , Czechia
1st Department of Medicine - Hematology, General University Hospital
Prague, , Czechia
Countries
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References
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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.
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].
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]
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.
Related Links
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Czech CLL Study Group
Other Identifiers
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BR-1
Identifier Type: -
Identifier Source: org_study_id
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