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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
B-cell Chronic Lymphocytic Leukemia

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate (complete and partial response rate)

Principal Investigator

Andreas Engert

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cologne

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CLL-2L

NCT ID:

NCT00147901

Start Date:

January 2005

Completion Date:

Related Keywords:

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

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