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Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

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ClinicalTrials.gov Identifier: NCT00943709
Recruitment Status : Withdrawn (lack of accrual)
First Posted : July 22, 2009
Last Update Posted : August 30, 2013
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Sanofi
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Description
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Brief Summary:

RATIONALE: Controlling blood sugar levels may be effective in preventing infections in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.

PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic leukemia.


Condition or disease Intervention/treatment Phase
Hyperglycemia Leukemia Biological: insulin glargine recombinant Drug: therapeutic insulin Phase 3

Detailed Description:

OBJECTIVES:

Primary

  • To determine whether intensive glycemic control over an eight week time period will decrease the incidence of infections from initiation of chemotherapy treatment in patients with acute myeloid leukemia or acute lymphoblastic leukemia.

Secondary

  • To compare the number of episodes of infection.
  • To compare the duration of neutropenia.
  • To compare the number of days of bacteremia/fungemia.
  • To compare the number of days of fever.
  • To compare the duration of nutrition.
  • To compare the duration of mucositis.
  • To compare the duration of hospital stay.
  • To compare the duration of antibiotic use.
  • To compare the incidence of thromboembolic events.
  • To compare body weight changes.
  • To compare the median survival.
  • To compare the remission rate with induction or salvage chemotherapy.
  • To conduct comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I (intensive glycemic control): Patients with goal blood glucose 80-140 mg/dL receive the Robert Wood Johnson University Hospital IV insulin infusion protocol to maintain blood glucoses in the target range. Beginning 24 hours after maintenance of oral or enteral feedings patients receive an intensive regimen of insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks as needed. Patients may also receive insulin in the total parenteral nutrition (TPN) mixture.
  • Arm II (standard care control): Patients with goal blood glucose < 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale. Insulin may also be added to TPN if needed at the investigator's discretion.

After completion of study treatment, patients are followed up for 4 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
Study Start Date : May 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Patients with goal blood glucose 80-14 mg/dL receive the Robert Wood Johnson Hospital IV insulin infusion protocol followed by insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks.
 Biological: insulin glargine recombinant
Given subcutaneously

Drug: therapeutic insulin
Given subcutaneously
Active Comparator: Arm II
Patients with goal blood glucose < 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale.
 Biological: insulin glargine recombinant
Given subcutaneously

Drug: therapeutic insulin
Given subcutaneously


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of new infections [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Number of episodes of infection [ Time Frame: 4 years ]
  2. Duration of neutropenia [ Time Frame: 4 years ]
  3. Number of days of bacteremia/fungemia [ Time Frame: 4 years ]
  4. Number of days of fever [ Time Frame: 4 years ]
  5. Duration of nutrition [ Time Frame: 4 years ]
  6. Duration of mucositis [ Time Frame: 4 years ]
  7. Duration of hospital stay [ Time Frame: 4 years ]
  8. Duration of antibiotic use [ Time Frame: 4 years ]
  9. Incidence of thromboembolic events [ Time Frame: 4 years ]
  10. Body weight changes [ Time Frame: 4 years ]
  11. Median survival [ Time Frame: 4 years ]
  12. Remission rate with induction or salvage chemotherapy [ Time Frame: 4 years ]
  13. Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed acute myeloid leukemia or acute lymphoid leukemia

    • Newly diagnosed or relapsed disease
  • Undergoing induction or salvage chemotherapy treatment
  • Must demonstrate 2 random blood sugars of ≥ 140 mg/dL while on total parenteral nutrition (TPN) OR 2 preprandial sugars of ≥ 140 mg/dL if patient is not on TPN

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Not pregnant or nursing
  • Negative pregnancy test
  • Prior diagnosis of diabetes mellitus allowed
  • No known history of an allergy to insulin
  • No documented active infection

PRIOR CONCURRENT THERAPY:

  • Concurrent corticosteroids allowed
  • No concurrent oral hypoglycemic agents
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00943709


Locations
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United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Sanofi
Investigators
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Principal Investigator: Mecide Gharibo, MD Rutgers Cancer Institute of New Jersey
More Information
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Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00943709    
Other Study ID Numbers: 060601
AVENTIS-CINJ-060601
0220070268 ( Other Identifier: IRB Number )
CDR0000648982
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013
Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
hyperglycemia
recurrent adult acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
 adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
Additional relevant MeSH terms:
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Leukemia
Hyperglycemia
Neoplasms by Histologic Type
Neoplasms
Glucose Metabolism Disorders
Metabolic Diseases
 Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs