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NCT02381899 Clinical Trial

Observational Study in CLL Patients Receiving BR

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
Observational Study in Comorbid Patients With Chronic Lymphocytic Leukemia Receiving First-line Bendamustine With Rituximab

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02381899
Other study ID # BR-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date December 2018

Study information
Verified date January 2019
Source Czech CLL Study Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date December 2018
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
Czechia Department of Hematology - Oncology, University Hospital Brno
Czechia 4th Department of Medicine - Hematology, University Hospital Hradec Kralove
Czechia Department of Hematology, University Hospital Plzen
Czechia 1st Department of Medicine - Hematology, General University Hospital Praha
Czechia Department of Medicine - Hematology, University Hospital Kralovske Vinohrady Praha

Sponsors (1)
Lead Sponsor Collaborator
Czech CLL Study Group

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

Fischer K, Cramer P, Busch R, Böttcher S, Bahlo J, Schubert J, Pflüger KH, Schott S, Goede V, Isfort S, von Tresckow J, Fink AM, Bühler A, Winkler D, Kreuzer KA, Staib P, Ritgen M, Kneba M, Döhner 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. — View 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

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. XV

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary Progression-free survival Calculated from the start of therapy until disease progression or death 3 years
Secondary Overall survival Time interval from the start of therapy until death form any cause 3 years
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