Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
NCT ID: NCT00943709
Last Updated: 2013-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2009-05-31
2010-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
insulin glargine recombinant
Given subcutaneously
therapeutic insulin
Given subcutaneously
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.
insulin glargine recombinant
Given subcutaneously
therapeutic insulin
Given subcutaneously
Interventions
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insulin glargine recombinant
Given subcutaneously
therapeutic insulin
Given subcutaneously
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sanofi
INDUSTRY
University of Medicine and Dentistry of New Jersey
OTHER
Responsible Party
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Principal Investigators
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Mecide Gharibo, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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AVENTIS-CINJ-060601
Identifier Type: -
Identifier Source: secondary_id
0220070268
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000648982
Identifier Type: -
Identifier Source: secondary_id
060601
Identifier Type: -
Identifier Source: org_study_id