Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)
|Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage III Small Lymphocytic Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Small Lymphocytic Lymphoma||Drug: Bendamustine Hydrochloride Biological: Alemtuzumab||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Bendamustine Plus Alemtuzumab for the Treatment of Fludarabine Refractory Chronic Lymphocytic Leukemia|
- Evaluate the safety of the combination of alemtuzumab and bendamustine in patients with advanced CLL [ Time Frame: up to 1 year ]AEs will be graded according to the NCI CTCAE, Version 3.0.
- Establish the maximum tolerated dose of alemtuzumab up to the standard dose of 30mg thrice weekly when combined with bendamustine at a standard dose of 70 mg/m2 day 8 and 9 monthly. [ Time Frame: up to 12 weeks ]Adverse events (AEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
- Clinical activity and response of the combination of bendamustine hydrochloride and alemtuzumab [ Time Frame: up to 1 year ]Examined by summarizing response overall and by cohort as frequency counts and percentages. Response criteria as described by the National Cancer Institute-sponsored Working Group Guidelines.
|Study Start Date:||November 2008|
|Study Completion Date:||March 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Experimental: Bendamustine plus Alemtuzumab||
Drug: Bendamustine Hydrochloride
Bendamustine 70 mg/m2 IV Day 8 and 9 every 28 days for 6 courses of therapy
Other Names:Biological: Alemtuzumab
Given subcutaneously (SC)on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.
I. Evaluate the safety of the combination of alemtuzumab and bendamustine (bendamustine hydrochloride) in patients with advanced CLL.
II. Establish the maximum tolerated dose of alemtuzumab up to the standard dose of 30mg thrice weekly when combined with bendamustine at a standard dose of 70 mg/m^2 day 8 and 9 monthly.
III. Define a recommended dose for subsequent Phase II studies. IV. Evaluate preliminary evidence of activity as determined by response rates with correlation to EAS flow cytometry.
OUTLINE: This is a dose-escalation study of alemtuzumab.
Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 8 and 9 for up to 6 courses in the absence of disease progression or unacceptable toxicity and alemtuzumab subcutaneously (SC) on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.
After completion of study treatment, patients are followed every 3 months for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947388
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Matt Kalaycio, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Principal Investigator:||Paolo Caimi, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|