Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)

B-cell Chronic Lymphocytic Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147901
• Other study ID #: CLL-2L
• Secondary ID: 2005-003017-32
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: September 30, 2016
• Start date: January 2005
• Est. completion date: November 2011

Study information

• Verified date: September 2016
• Source: German CLL Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2011
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-cell Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne	NRW

Sponsors (3)

Lead Sponsor	Collaborator
German CLL Study Group	MedacSchering Onkologie, University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Elter T, James R, Busch R, Winkler D, Ritgen M, Böttcher S, Kahl C, Gassmann W, Stauch M, Hasan I, Staib P, Fischer K, Fink AM, Bahlo J, Bühler A, Döhner H, Wendtner CM, Stilgenbauer S, Engert A, Hallek M. Fludarabine and cyclophosphamide in combination w — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (complete and partial response rate)	Response Evaluation has to be done according the the NCI guidelines	28 days after the end of the last cycle	No
Secondary	Toxicity		28 days following the last dose of FCCam	Yes
Secondary	MRD response rate		28 days after the end of the last cycle	No
Secondary	Response rate in biological defined risk groups		28 days after the end of the last cycle	No
Secondary	Duration of response		up to 36 months after the end of treatment	No
Secondary	Treatment administration (dose intensity)		up to the last day of the last given cycle (day 28 of the 6th cycle)	No
Secondary	Overall survival		up to 36 months after the end of treatment	No

External Links

•   Click here for more information about this study: CLL-2L (German CLL Study Group)