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Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Kreitman, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00077922
First received: February 12, 2004
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
Results First Received: October 17, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphocytic
Chronic
Intervention: Drug: LMB-2

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
LMB-2 in Chronic Lymphocytic Leukemia 40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.

Participant Flow:   Overall Study
    LMB-2 in Chronic Lymphocytic Leukemia  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
LMB-2 in Chronic Lymphocytic Leukemia 40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.

Baseline Measures
    LMB-2 in Chronic Lymphocytic Leukemia  
Number of Participants  
[units: participants]
 		  15  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation 		  61.36  ± 7.6  
Gender  
[units: participants]
 		 
Female     5  
Male     10  
Ethnicity (NIH/OMB)  
[units: Participants]
 		 
Hispanic or Latino     1  
Not Hispanic or Latino     14  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: Participants]
 		 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     13  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 		 
United States     15  



  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: Patients were followed for at least 30 days after last treatment. Because the study allows 6 treatment cycles, this can be up to 7 months. ]
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2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 54 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Robert J. Kreitman, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-6947
e-mail: kreitmar@mail.nih.gov


Publications:


Responsible Party: Robert Kreitman, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00077922     History of Changes
Obsolete Identifiers: NCT00080821
Other Study ID Numbers: 040121, 04-C-0121
Study First Received: February 12, 2004
Results First Received: October 17, 2012
Last Updated: October 17, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration