Clinical trial NCT02381899: Observational Study in CLL Patients Receiving BR
Official title: Observational Study in Comorbid Patients With Chronic Lymphocytic Leukemia Receiving First-line Bendamustine With Rituximab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: chronic lymphocytic leukemia
bendamustine
rituximab
Lead sponsor: Czech CLL Study Group
Sponsor class: NETWORK
First posted: 2015-03-06
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic lymphocytic leukemia.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of chronic lymphocytic leukemia
* Patients treated with first-line BR for active disease requiring treatment
* Cumulative Illness Rating Scale (CIRS) \> 6
* Informed consent to data collection

Exclusion Criteria:

* Patients treated with BR within prospective clinical trials

Primary outcomes:
measure: Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria
timeFrame: 8 months
measure: Overall response rate
timeFrame: 8 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Department of Hematology - Oncology, University Hospital
city: Hradec Kralove
country: Czechia
facility: 4th Department of Medicine - Hematology, University Hospital
city: Plzen
country: Czechia
facility: Department of Hematology, University Hospital
city: Praha
country: Czechia
facility: Department of Medicine - Hematology, University Hospital Kralovske Vinohrady
city: Praha
country: Czechia
facility: 1st Department of Medicine - Hematology, General University Hospital
Study officials:
affiliation: Czech CLL Study Group
name: Martin Spacek, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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].
citation: 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]
citation: 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.