We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00500240
First Posted: July 12, 2007
Last Update Posted: June 3, 2015
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.
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: June 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Interventions: Drug: Insulin Glargine
Drug: Insulin Aspart

  Participant Flow
  Hide 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: 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
  Hide 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
  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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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

2.  Primary:   Overall Survival   [ Time Frame: Baseline (date of randomization) to date of death or last follow-up (weekly during treatment then every 2 months post study treatment) up to 6 years ]

3.  Primary:   Progression Free Survival (PFS)   [ Time Frame: Date of complete remission to disease progression, assessed for approximately 6 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Study terminated early due to futility at the pre-determined interim analysis point.


  More Information
  Hide More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500240     History of Changes
Other Study ID Numbers: 2004-0107
First Submitted: July 10, 2007
First Posted: July 12, 2007
Results First Submitted: June 5, 2013
Results First Posted: August 7, 2014
Last Update Posted: June 3, 2015