Phase 2 Fludarabine, Cytoxan and FCCAM <Alemtuzumab> in Untreated B-Cell Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Steven E. Coutre, Stanford University
ClinicalTrials.gov Identifier:
NCT00230282
First received: September 28, 2005
Last updated: September 8, 2014
Last verified: September 2014
Results First Received: August 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
B-cell Leukemia
Chronic Leukemia
Chronic Lymphocytic Leukemia (CLL)
Interventions: Drug: Alemtuzumab
Drug: Fludarabine
Drug: Cytoxan

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fludarabine and Cyclophosphamide, Followed by Alemtuzumab Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).

Participant Flow for 2 periods

Period 1:   Fludarabine + Cyclophosphamide
    Fludarabine and Cyclophosphamide, Followed by Alemtuzumab  
STARTED     25  
COMPLETED     17  
NOT COMPLETED     8  
Lost to Follow-up                 4  
Withdrawal by Subject                 1  
Change in diagnosis                 1  
Richters transformation (progression)                 2  

Period 2:   Maintanence Therapy With Alemtuzumab
    Fludarabine and Cyclophosphamide, Followed by Alemtuzumab  
STARTED     17  
COMPLETED     17  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fludarabine and Cyclophosphamide, Followed by Alemtuzumab Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).

Baseline Measures
    Fludarabine and Cyclophosphamide, Followed by Alemtuzumab  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     12  
Gender  
[units: participants]
 
Female     11  
Male     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Maintaining Partial Response (PR) or Complete Response (CR)   [ Time Frame: 24 weeks ]

2.  Secondary:   Duration of Response   [ Time Frame: 105 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steven E. Coutre, Associate Professor of Medicine
Organization: Stanford University
phone: 650-723-6661
e-mail: coutre@stanford.edu


No publications provided


Responsible Party: Steven E. Coutre, Stanford University
ClinicalTrials.gov Identifier: NCT00230282     History of Changes
Other Study ID Numbers: IRB-13053, 31185, 80071, HEMCLL0001
Study First Received: September 28, 2005
Results First Received: August 27, 2014
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board