The primary objective of this study is 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 according to NCI response criteria (also established according to IWCLL guidelines) upon treatment with a combination of bendamustine and alemtuzumab.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
Innsbruck, Tyrol, Austria
Landeskrankenhaus Feldkirch
Feldkirch, Austria
A.ö. Landeskrankenhaus Leoben
Leoben, Austria
Krankenhaus der Elisabethinen Linz
Linz, Austria
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
Time frame: 2 -16 months
To evaluate the efficacy of a bendamustine/ alemtuzumab combination therapy in terms of complete response rates
Time frame: 2 - 16 months
To evaluate the achievable cumulative doses of bendamustine and alemtuzumab in terms of maximum tolerated doses while on treatment
Time frame: 2 -16 months
To determine response rates in all phases by 4-colour flow cytometric MRD analysis
Time frame: 2 -16 months
To identify and characterize potential risk factors via FISH cytogenetics, CD38/ Zap-70 expression and mutational status
Time frame: 2 - 6 months
To define clonal evolution by use of longitudinal FISH cytogenetics
Time frame: 2 - 6 months
To define T cell subsets including prognostic EM T cells and Treg cells
Time frame: 2 - 16 months
To document change upon quality of life by use of a standardized QoL questionnaire
Time frame: 2 -16 months
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Krankenhaus der Stadt Linz
Linz, Austria
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria