Bendamustine Combined With Alemtuzumab in Pretreated Chronic Lymphocytic Leukemia (CLL) - A Phase I/II Trial With Concomitant Evaluation of Safety and Efficacy
This is a non-randomized, multicenter, open-label, single-arm Phase I/II study to evaluate
the safety and efficacy of bendamustine combined with alemtuzumab in patients with
pretreated CD20-positive CLL (according to the revised NCI/ IWCLL criteria).
Eligible patients will receive bendamustine as 4 courses of 70 mg/m2 on days 1 and 2 every
28 days and 30 mg alemtuzumab s.c. continuously on days 1, 3 and 5 of every week, for a
maximum of 16 weeks. Safety assessments will be conducted weekly; efficacy assessments
including imaging will be performed at months 2, 4, 6, 10 and 16. Bone marrow biopsies will
be performed upon CR (according to the 2008 IWCLL response criteria) or fixed at 6 and 16
months.
Following recruitment of the first 3 and 7 patients safety evaluations will be performed by
a data safety monitoring board. An interim analysis for response and safety as well as
maximum tolerated dose levels will occur after the first 7 patients have completed treatment
(Gehan timepoint). If the treatment is deemed clinically safe a further 13 patients will be
enrolled.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the percentage of patients achieving a response, defined as the percentage of patients achieving complete response, partial response and stable disease/ no change upon treatment with the combination therapy
2 -16 months
No
Richard Greil, Prof.Dr.
Study Chair
Arbeitsgemeinschaft medikamentoese Tumortherapie
Austria: Agency for Health and Food Safety
AGMT CLL-6 BendAlem
NCT00951457
March 2009
June 2013
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