Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage

This study has been completed.
Sponsor:
Collaborator:
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00890656
First received: April 29, 2009
Last updated: February 17, 2012
Last verified: February 2012
Results First Received: July 25, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Lymphoblastic Leukemia
Interventions: Drug: Cyclophosphamide (CTX)
Drug: Vincristine
Drug: Doxorubicin
Drug: Decadron
Drug: G-CSF
Drug: Methotrexate (MTX)
Drug: Ara-C
Drug: Pegaspargase

  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: 6/9/2003 to 10/12/2009. 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
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Reporting Groups
  Description
Augmented Hyper-CVAD Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.

Participant Flow:   Overall Study
    Augmented Hyper-CVAD  
STARTED     90  
COMPLETED     90  
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
Augmented Hyper-CVAD Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.

Baseline Measures
    Augmented Hyper-CVAD  
Number of Participants  
[units: participants]
  90  
Age  
[units: years]
Median ( Full Range )
  34  
  ( 14 to 70 )  
Gender  
[units: participants]
 
Female     40  
Male     50  
Region of Enrollment  
[units: participants]
 
United States     90  



  Outcome Measures

1.  Primary:   Number of Participants With Complete Remission   [ Time Frame: Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses. ]


  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: Stefan Fader, M.D./Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713/745-4613
e-mail: eharriso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00890656     History of Changes
Other Study ID Numbers: ID03-0166
Study First Received: April 29, 2009
Results First Received: July 25, 2011
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board