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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Drug: Insulin Glargine Drug: Insulin Aspart Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Tight Control of Blood Glucose During Hyper-CVAD Chemotherapy For Acute Lymphocytic Leukemia
Study Start Date : April 2004
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Arm Intervention/treatment
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
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00500240

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novo Nordisk A/S
Principal Investigator: Khanh Vu, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00500240     History of Changes
Other Study ID Numbers: 2004-0107
First Posted: July 12, 2007    Key Record Dates
Results First Posted: August 7, 2014
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by M.D. Anderson Cancer Center:
Acute Lymphocytic Leukemia
Burkitts Lymphoma
Lymphoblastic Leukemia
Blood Sugar
Insulin Aspart
Insulin Glargine

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs