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

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. Identifier: NCT00500240
Recruitment Status : Terminated (Terminated early due to futility.)
First Posted : July 12, 2007
Results First Posted : August 7, 2014
Last Update Posted : June 3, 2015
Novo Nordisk A/S
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

July 10, 2007
July 12, 2007
June 5, 2013
August 7, 2014
June 3, 2015
April 2004
April 2012   (Final data collection date for primary outcome measure)
  • 1-Year Overall Survival Rate [ Time Frame: 1 year ]
    The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months.
  • 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 ]
    Overall survival (OS) defined as the interval between the date of randomization and the date of death. Calculation of period was from baseline (date of randomization) to the death or last follow-up.
  • Progression Free Survival (PFS) [ Time Frame: Date of complete remission to disease progression, assessed for approximately 6 years ]
    PFS was defined as the time interval between the date of complete remission and the date of relapse detection or death. Complete Remission (CR) defined as granulocyte count >1.0 × 10^9/L, platelet count >100 × 10^9/L, no abnormal peripheral blasts, and <5% blasts in normocellular or hypercellular bone marrow.
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Complete list of historical versions of study NCT00500240 on Archive Site
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Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia (ALL)
Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia
The goal of this clinical research study is to learn if intense management and control of blood sugar levels during treatment for acute lymphocytic leukemia, Burkitts lymphoma, or lymphoblastic lymphoma will result in decreased risk of relapse, fewer complications, and/or longer survival.

High blood sugar is a common side effect of treatment for certain types of cancer.

You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive blood sugar management with regular human insulin. Participants in the other group will receive more intense management with two newer forms of human insulin - insulin aspart, for rapid lowering of the blood glucose and insulin glargine for the slow decrease of blood sugar level over 24 hours.

You will receive additional blood tests (about 1 tablespoon each) at the time of entry on the study and after about every 2 to 4 courses of chemotherapy while on the study. These blood tests help better define the severity of your high blood sugar and your body's ability to metabolize sugar. Any bone marrow and blood samples that were collected before your therapy for your leukemia may be used for lab tests to measure markers of glucose metabolism in the blood. You will not be required to have a bone marrow biopsy after enrollment on study.

While in the hospital receiving chemotherapy, you will have your blood sugar checked 3 to 4 times a day. To check your blood sugar level, you, your nurse, or a laboratory technician will prick your finger with a small needle and place a small drop of blood on a test strip. If your blood sugar is high, you will be given the appropriate amount of insulin.

Before you begin out-patient insulin treatment, a research nurse, doctor, or diabetes educator will watch how you and/or your caregiver administer your insulin shots, to make sure that it is done correctly and safely. Once you leave the hospital, you will be required to check your own blood sugar 3 times a day and take insulin (either yourself or with the help of a health provider) up to 4 times a day while on steroid therapy and for 2 days after receiving steroids. On all other days you will be required to check your blood glucose once or twice a day and administer insulin 1 - 3 times daily. You will also need to speak with a nurse by phone every 1-3 days for review of blood sugar measurements and possible adjustment of the dose of insulin you must take.

You will remain on the study from the time you are found to have high blood sugar levels until completion of your chemotherapy (about 8 months for most patients). You may be taken off this study at any time if you find that you are unable or unwilling to monitor your glucose or receive insulin shots at home.

You will be followed for high blood sugar levels while you are receiving treatment with Hyper-CVAD chemotherapy regimen (fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating cycles with methotrexate, cytarabine, methylprednisolone). If you continue to have high blood sugar after completion of this treatment, you will have continued follow-up either with your primary physician at home or if you choose, in the Internal Medicine Clinic at M. D. Anderson.

This is an investigational study. All of the insulin used in this study is FDA approved for the treatment of high blood sugar and commercially available. A total of up to 114 patients will take part in this study. All will be enrolled at M. D. Anderson.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Drug: Insulin Glargine
    Use of human insulin glargine for slow decrease of blood sugar level over 24 hours.
  • Drug: Insulin Aspart
    Use of human insulin aspart for rapid lowering of the blood glucose level over 24 hours.
  • No Intervention: 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
    • Drug: Insulin Glargine
    • Drug: Insulin Aspart
Vu K, Busaidy N, Cabanillas ME, Konopleva M, Faderl S, Thomas DA, O'Brien S, Broglio K, Ensor J, Escalante C, Andreeff M, Kantarjian H, Lavis V, Yeung SC. A randomized controlled trial of an intensive insulin regimen in patients with hyperglycemic acute lymphoblastic leukemia. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):355-62. doi: 10.1016/j.clml.2012.05.004. Epub 2012 Jun 1.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age >/= 15 years.
  2. Previously untreated ALL, Burkitt's lymphoma, or lymphoblastic leukemia receiving induction chemotherapy with hyper-CVAD or variants of the hyper-CVAD regimen.
  3. Random serum glucose >/= 180 mg/dL detected during the first 2 cycles of chemotherapy and confirmed with a second measurement.

Exclusion Criteria:

  1. History of Type I diabetes mellitus.
  2. Pregnancy or breast feeding.
  3. Allergy to insulin or insulin products.
  4. On-going treatment of steroid-induced hyperglycemia by an endocrinologist and/or general internist.
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Novo Nordisk A/S
Principal Investigator: Khanh Vu, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP