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

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ClinicalTrials.gov Identifier: NCT00147901
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : October 3, 2016
Sponsor:
Collaborators:
University of Cologne
MedacSchering Onkologie
Information provided by (Responsible Party):
German CLL Study Group

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

Condition or disease Intervention/treatment Phase
B-cell Chronic Lymphocytic Leukemia Drug: FCCam Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : January 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2011


Arm Intervention/treatment
Experimental: 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
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
Other Name: Fludarabine, Cyclophosphamide, Alemtuzumab



Primary Outcome Measures :
  1. Overall response rate (complete and partial response rate) [ Time Frame: 28 days after the end of the last cycle ]
    Response Evaluation has to be done according the the NCI guidelines


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 28 days following the last dose of FCCam ]
  2. MRD response rate [ Time Frame: 28 days after the end of the last cycle ]
  3. Response rate in biological defined risk groups [ Time Frame: 28 days after the end of the last cycle ]
  4. Duration of response [ Time Frame: up to 36 months after the end of treatment ]
  5. Treatment administration (dose intensity) [ Time Frame: up to the last day of the last given cycle (day 28 of the 6th cycle) ]
  6. Overall survival [ Time Frame: up to 36 months after the end of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147901


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

Additional Information:
Publications of Results:
Responsible Party: German CLL Study Group
ClinicalTrials.gov Identifier: NCT00147901     History of Changes
Other Study ID Numbers: CLL-2L
2005-003017-32 ( EudraCT Number )
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by German CLL Study Group:
CLL
Immunochemotherapy

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Cyclophosphamide
Fludarabine phosphate
Fludarabine
Alemtuzumab
Vidarabine
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
Antimetabolites
Antiviral Agents
Anti-Infective Agents