Back to resultsFludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)
Primary Purpose
B-cell Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
FCCam
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia focused on measuring CLL, Immunochemotherapy
Eligibility Criteria
Inclusion Criteria: B-CLL in need of treatment One or two prior prior therapies WHO performance status 0-2 Exclusion Criteria: Serum creatinine > 1.5 ULN Major organ dysfunctions Pregnant or nursing
Sites / Locations
- University of Cologne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FCCam
Arm Description
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
Outcomes
Primary Outcome Measures
Overall response rate (complete and partial response rate)
Response Evaluation has to be done according the the NCI guidelines
Secondary Outcome Measures
Toxicity
MRD response rate
Response rate in biological defined risk groups
Duration of response
Treatment administration (dose intensity)
Overall survival
Full Information
NCT ID
NCT00147901
First Posted
September 2, 2005
Last Updated
September 30, 2016
Sponsor
German CLL Study Group
Collaborators
University of Cologne, MedacSchering Onkologie
1. Study Identification
Unique Protocol Identification Number
NCT00147901
Brief Title
Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)
Official Title
Multicenter Phase II Trial of Fludarabine and Cyclophosphamide in Combination With Alemtuzumab (FC-Cam) for Patients With Relapsed Chronic Lymphocytic Leukemia - CLL-2L Protocol of the German CLL-Study Group (GCLLSG)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German CLL Study Group
Collaborators
University of Cologne, MedacSchering Onkologie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Chronic Lymphocytic Leukemia
Keywords
CLL, Immunochemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FCCam
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
FCCam
Other Intervention Name(s)
Fludarabine, Cyclophosphamide, Alemtuzumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall response rate (complete and partial response rate)
Description
Response Evaluation has to be done according the the NCI guidelines
Time Frame
28 days after the end of the last cycle
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
28 days following the last dose of FCCam
Title
MRD response rate
Time Frame
28 days after the end of the last cycle
Title
Response rate in biological defined risk groups
Time Frame
28 days after the end of the last cycle
Title
Duration of response
Time Frame
up to 36 months after the end of treatment
Title
Treatment administration (dose intensity)
Time Frame
up to the last day of the last given cycle (day 28 of the 6th cycle)
Title
Overall survival
Time Frame
up to 36 months after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
B-CLL in need of treatment
One or two prior prior therapies
WHO performance status 0-2
Exclusion Criteria:
Serum creatinine > 1.5 ULN
Major organ dysfunctions
Pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50924
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22584787
Citation
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.
Results Reference
result
Links:
URL
http://www.dcllsg.de/en/trial/cll2l/index.php
Description
Click here for more information about this study: CLL-2L (German CLL Study Group)
Learn more about this trial
Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)
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