Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)

This study has been terminated.
(Terminated early due to futility.)
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00500240
First received: July 10, 2007
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: June 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Interventions: Drug: Insulin Glargine
Drug: Insulin Aspart

  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: 04/27/2004 through 7/1/2008. All participants recruited at the University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifty-two participants were randomized to a conventional treatment arm or an intensive insulin intervention arm. One participant on the conventional control arm was excluded and did not receive allocated intervention.

Reporting Groups
  Description
Conventional Care Control Group: Conventional care using blood sugar management with regular human insulin.
Intensive Insulin Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine

Participant Flow:   Overall Study
    Conventional Care     Intensive Insulin  
STARTED     25     26  
COMPLETED     25     26  
NOT COMPLETED     0     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
Conventional Care Control Group: Conventional care using blood sugar management with regular human insulin.
Intensive Insulin Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
Total Total of all reporting groups

Baseline Measures
    Conventional Care     Intensive Insulin     Total  
Number of Participants  
[units: participants]
  25     26     51  
Age  
[units: years]
Median ( Full Range )
  46  
  ( 17 to 70 )  
  57.5  
  ( 18 to 85 )  
  52  
  ( 17 to 85 )  
Gender  
[units: participants]
     
Female     9     12     21  
Male     16     14     30  
Region of Enrollment  
[units: participants]
     
United States     25     26     51  



  Outcome Measures
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1.  Primary:   1-Year Progression Free Survival (PFS)   [ Time Frame: 1 Year ]

2.  Primary:   1-Year Overall Survival Rate   [ Time Frame: 1 year ]


  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
Study terminated early due to futility at the pre-determined interim analysis point.


  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: Khanh D Vu, MD/ Associated Professor
Organization: UT MD Anderson Cancer Center
phone: 713-745-4516
e-mail: eharriso@mdanderson.org


No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500240     History of Changes
Other Study ID Numbers: 2004-0107
Study First Received: July 10, 2007
Results First Received: June 5, 2013
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board