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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: July 27, 2016
Last verified: July 2016
Results First Received: November 19, 2009  
Study Type: Interventional
Study Design: 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 
Overall Participants Analyzed 
[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 
[1] Blood serum levels
Lymph node size [1] 
[Units: Participants]
 
< 5 centimeters (cm)   43 
>= 5 cm   12 
missing   5 
[1] Bidimensional measurement by palpation
Number of prior cancer therapies 
[Units: Participants]
 
 10 
 14 
 13 
 5 
5-10   16 
>10   2 
Rai Stage [1] 
[Units: Participants]
 
 5 
1 to 2   22 
3 to 4   33 
Missing   0 
[1] 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


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-us@sanofi.com



Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00206726     History of Changes
Other Study ID Numbers: 13603
305825 ( Other Identifier: Sanofi )
Study First Received: September 19, 2005
Results First Received: November 19, 2009
Last Updated: July 27, 2016
Health Authority: United States: Food and Drug Administration