Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL) (ECO-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00206726
First received: September 19, 2005
Last updated: December 2, 2013
Last verified: December 2013
Results First Received: November 19, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Drug: Alemtuzumab plus Fludarabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 27 centers in the United States from 12 May 2005 (date of first participant's first visit) to 10 April 2008 (date of last participant's last visit)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
66 screened, 6 screen failures, 60 enrolled and registered (Intent-to-Treat [ITT] population), 3 withdrew consent prior to receiving therapy = 57 treated (Safety population); 41 received at least 4 therapy cycles with no major protocol deviation or progressed/relapsed or died before completing 4 cycles (Per Protocol [PP] population)

Reporting Groups
  Description
Alemtuzumab Plus Fludarabine Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days

Participant Flow:   Overall Study
    Alemtuzumab Plus Fludarabine  
STARTED     60  
Treatment Started     57 [1]
4 Cycles Completed     41 [2]
COMPLETED     9 [3]
NOT COMPLETED     51  
Delayed recovery of blood counts                 1  
Progressive disease or relapsed disease                 18  
Placed on new protocol                 1  
Bone marrow transplant                 1  
Adverse Event                 17  
Death                 4  
Protocol Violation                 1  
Withdrawal by Subject                 8  
[1] Safety population (3 withdrew consent prior to receiving study drug)
[2] per protocol population
[3] 4-6 cycles of treatment with assessments at 2, 6, and 9 months post last dose



  Baseline Characteristics
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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
Alemtuzumab Plus Fludarabine Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days

Baseline Measures
    Alemtuzumab Plus Fludarabine  
Number of Participants  
[units: participants]
  60  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 37 to 86 )  
Gender  
[units: participants]
 
Female     19  
Male     41  
Beta 2-micro-globulin [1]
[units: Participants]
 
< 2 milligrams per liter (mg/L) or missing     12  
>= 2mg/L     48  
Lymph node size [2]
[units: participants]
 
< 5 centimeters (cm)     43  
>= 5 cm     12  
missing     5  
Number of prior cancer therapies  
[units: Participants]
 
1     10  
2     14  
3     13  
4     5  
5-10     16  
>10     2  
Rai Stage [3]
[units: participants]
 
0     5  
1 to 2     22  
3 to 4     33  
Missing     0  
[1] Blood serum levels
[2] Bidimensional measurement by palpation
[3] Staging system for chronic lymphocytic leukemia (CLL) based on lymphocyte count and percent lymphocytes in bone marrow plus enlarged lymph nodes, or enlarged spleen or liver, or anemia, or thrombocytopenia



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Response (CR)   [ Time Frame: 28 days after last cycle with confirmation 2 months later ]

2.  Secondary:   Overall Response (OR)   [ Time Frame: 28 days after last cycle with confirmation 2 months later ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: 1 year after start of treatment ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 1 year after start of treatment ]

5.  Secondary:   Percentage of Participants With Overall Response at Different Observation Times   [ Time Frame: from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier ]

6.  Secondary:   Number of Participants With Minimal Residual Disease (MRD)   [ Time Frame: When CR is confirmed ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00206726     History of Changes
Other Study ID Numbers: 13603
Study First Received: September 19, 2005
Results First Received: November 19, 2009
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration