Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)
NCT ID: NCT00147901
Last Updated: 2016-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2005-01-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FCCam
After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles
FCCam
After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles
Interventions
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FCCam
After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* One or two prior prior therapies
* WHO performance status 0-2
Exclusion Criteria
* Major organ dysfunctions
* Pregnant or nursing
18 Years
ALL
No
Sponsors
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University of Cologne
OTHER
MedacSchering Onkologie
UNKNOWN
German CLL Study Group
OTHER
Responsible Party
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Principal Investigators
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Andreas Engert
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
Locations
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University of Cologne
Cologne, North Rhine-Westphalia, Germany
Countries
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References
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Elter T, James R, Busch R, Winkler D, Ritgen M, Bottcher S, Kahl C, Gassmann W, Stauch M, Hasan I, Staib P, Fischer K, Fink AM, Bahlo J, Buhler A, Dohner H, Wendtner CM, Stilgenbauer S, Engert A, Hallek M. Fludarabine and cyclophosphamide in combination with alemtuzumab in patients with primary high-risk, relapsed or refractory chronic lymphocytic leukemia. Leukemia. 2012 Dec;26(12):2549-52. doi: 10.1038/leu.2012.129. Epub 2012 May 15. No abstract available.
Other Identifiers
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2005-003017-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLL-2L
Identifier Type: -
Identifier Source: org_study_id
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