Alemtuzumab and Pentostatin In T-cell Neoplasms

This study has been terminated.
(Slow accrual.)
Sponsor:
Collaborators:
Astex Pharmaceuticals
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00453193
First received: March 26, 2007
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: March 1, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma
Leukemia
Interventions: Drug: Pentostatin
Drug: 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
Recruitment Period: 8/241/2004 to 5/12/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 26 enrolled, only 24 patients were included in this study.

Reporting Groups
  Description
Alemtuzumab + Pentostatin Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks

Participant Flow:   Overall Study
    Alemtuzumab + Pentostatin  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  



  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 + Pentostatin Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks

Baseline Measures
    Alemtuzumab + Pentostatin  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Median ( Full Range )
  57  
  ( 21 to 79 )  
Gender  
[units: participants]
 
Female     10  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     24  



  Outcome Measures

1.  Primary:   Number of Participants With Objective Response   [ Time Frame: After a maximum of 6 months of therapy maintained for one month. ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Farhad Ravandi-Kashani MD/Associate Professor
Organization: The University of Texas M D Anderson Cancer Center
phone: 713-745-0394
e-mail: eharriso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00453193     History of Changes
Other Study ID Numbers: 2004-0408
Study First Received: March 26, 2007
Results First Received: March 1, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board