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Alemtuzumab and Pentostatin In T-cell Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00453193
Recruitment Status : Terminated (Slow accrual.)
First Posted : March 28, 2007
Results First Posted : March 28, 2011
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma
Interventions: Drug: Pentostatin
Drug: Alemtuzumab

  Participant Flow

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
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

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (21 to 79) 
[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

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.

  More Information

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

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00453193     History of Changes
Other Study ID Numbers: 2004-0408
First Submitted: March 26, 2007
First Posted: March 28, 2007
Results First Submitted: March 1, 2011
Results First Posted: March 28, 2011
Last Update Posted: August 7, 2012