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Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01099202
First received: April 5, 2010
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: Procrit (epoetin alfa)

  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 3/11/2003 - 5/25/2011; all patients were 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
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Reporting Groups
  Description
Procrit Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
No Procrit No intervention.

Participant Flow:   Overall Study
    Procrit     No Procrit  
STARTED     55     54  
COMPLETED     55     54  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Procrit Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
No Procrit No intervention.
Total Total of all reporting groups

Baseline Measures
    Procrit     No Procrit     Total  
Number of Participants  
[units: participants]
 		  55     54     109  
Age  
[units: years]
Median ( Full Range ) 		  39  
  ( 18 to 76 )   		  42  
  ( 15 to 84 )   		  41  
  ( 15 to 84 )  
Gender  
[units: participants]
 		     
Female     22     30     52  
Male     33     24     57  
Region of Enrollment  
[units: participants]
 		     
United States     55     54     109  



  Outcome Measures
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1.  Primary:   Mean Number of RBC Units Transfused During Initial 5 Months of Treatment   [ Time Frame: 5 weeks to 5 Months ]
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2.  Primary:   Number of PRBC Transfusions During Initial 5 Months of Treatment   [ Time Frame: 5 weeks to 5 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: Jorge Cortes M.D./Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713/794-5783
e-mail: eharriso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01099202     History of Changes
Other Study ID Numbers: ID02-591
Study First Received: April 5, 2010
Results First Received: June 12, 2012
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board