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

This study has been completed.
Sponsor:
Collaborators:
University of Cologne
MedacSchering Onkologie
Information provided by (Responsible Party):
German CLL Study Group
ClinicalTrials.gov Identifier:
NCT00147901
First received: September 2, 2005
Last updated: August 8, 2016
Last verified: August 2016
  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: FCCam
Phase 2

Study Type: Interventional
Study Design: 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 German CLL Study Group:

Primary Outcome Measures:
  • Overall response rate (complete and partial response rate) [ Time Frame: 28 days after the end of the last cycle ] [ Designated as safety issue: No ]
    Response Evaluation has to be done according the the NCI guidelines


Secondary Outcome Measures:
  • Toxicity [ Time Frame: 28 days following the last dose of FCCam ] [ Designated as safety issue: Yes ]
  • MRD response rate [ Time Frame: 28 days after the end of the last cycle ] [ Designated as safety issue: No ]
  • Response rate in biological defined risk groups [ Time Frame: 28 days after the end of the last cycle ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: up to 36 months after the end of treatment ] [ Designated as safety issue: No ]
  • Treatment administration (dose intensity) [ Time Frame: up to the last day of the last given cycle (day 28 of the 6th cycle) ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 36 months after the end of treatment ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: January 2005
Study Completion Date: November 2011
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
German CLL Study Group
University of Cologne
MedacSchering Onkologie
Investigators
Principal Investigator: Andreas Engert University of Cologne
  More Information

Responsible Party: German CLL Study Group
ClinicalTrials.gov Identifier: NCT00147901     History of Changes
Other Study ID Numbers: CLL-2L 
Study First Received: September 2, 2005
Last Updated: August 8, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
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

ClinicalTrials.gov processed this record on August 24, 2016