A Phase I Trial of Bendamustine Plus Alemtuzumab for the Treatment of Fludarabine Refractory Chronic Lymphocytic Leukemia
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety of the combination of alemtuzumab and bendamustine in patients with advanced CLL
AEs will be graded according to the NCI CTCAE, Version 3.0.
up to 1 year
Matt Kalaycio, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Institutional Review Board
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|