Study to Evaluate the Combination of Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)

This study has been completed.
German CLL Study Group
MedacSchering Onkologie
Information provided by:
University of Cologne Identifier:
First received: September 2, 2005
Last updated: January 26, 2010
Last verified: January 2010
This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.

Condition Intervention Phase
B-cell Chronic Lymphocytic Leukemia
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Alemtuzumab
Phase 2

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

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Overall response rate (complete and partial response rate)

Secondary Outcome Measures:
  • Toxicity
  • MRD response rate
  • Response rate in biological defined risk groups
  • Duration of response
  • Treatment administration (dose intensity)
  • Overall survival

Estimated Enrollment: 100
Study Start Date: January 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00147901

University of Cologne
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
German CLL Study Group
MedacSchering Onkologie
Principal Investigator: Andreas Engert University of Cologne
  More Information Identifier: NCT00147901     History of Changes
Other Study ID Numbers: CLL-2L 
Study First Received: September 2, 2005
Last Updated: January 26, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents processed this record on July 24, 2016