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Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00061048
First received: May 20, 2003
Last updated: October 26, 2012
Last verified: October 2012
Results First Received: May 17, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute T-Cell Leukemia-Lymphoma
Intervention: Biological: Alemtuzumab

  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
Anticipate enrolling 10-12 patients per year into the Campath-1H trial. Thus, if the trial goes to completion (2nd stage)we anticipate enrolling the 29 patients in approximately 2.5 years.

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
Campath-1H Treatment of Adult T-cell Leukemia (ATL) Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.

Participant Flow:   Overall Study
    Campath-1H Treatment of Adult T-cell Leukemia (ATL)  
STARTED     29  
COMPLETED     7 [1]
NOT COMPLETED     22  
Adverse Event                 2  
disease progression                 20  
[1] Began protocol specified follow-up period.



  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
Campath-1H Treatment of Adult T-cell Leukemia (ATL) Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.

Baseline Measures
    Campath-1H Treatment of Adult T-cell Leukemia (ATL)  
Number of Participants  
[units: participants]
  29  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  52.54  ± 13.39  
Gender  
[units: participants]
 
Female     19  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     29  



  Outcome Measures
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1.  Primary:   Overall Response Rate   [ Time Frame: 60 months ]

2.  Primary:   Overall Survival   [ Time Frame: 60 months ]

3.  Primary:   Time to Progression   [ Time Frame: 60 months ]

4.  Secondary:   Cell Surface Expression of CD52 on Tumor Cells   [ Time Frame: 6 months ]

5.  Secondary:   The Number of Participants With Adverse Events   [ Time Frame: 18 months ]


  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: Thomas A. Waldmann, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-6653
e-mail: Thomas.Waldmann2@nih.gov


Publications:
Publications automatically indexed to this study:

Responsible Party: Thomas A. Waldmann, M.D., National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00061048     History of Changes
Obsolete Identifiers: NCT00064155
Other Study ID Numbers: 030194, 03-C-0194, 030194
Study First Received: May 20, 2003
Results First Received: May 17, 2011
Last Updated: October 26, 2012
Health Authority: United States: Federal Government