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.
Sponsor:
Collaborators:
German CLL Study Group
MedacSchering Onkologie
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00147901
First received: September 2, 2005
Last updated: January 26, 2010
Last verified: January 2010
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147901

Locations
Germany
University of Cologne
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
German CLL Study Group
MedacSchering Onkologie
Investigators
Principal Investigator: Andreas Engert University of Cologne
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov 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:
CLL
Immunochemotherapy

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Alemtuzumab
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014