Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

This study has been withdrawn prior to enrollment.
(lack of accrual)
Sponsor:
Collaborators:
Sanofi
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00943709
First received: July 21, 2009
Last updated: August 29, 2013
Last verified: August 2013

July 21, 2009
August 29, 2013
May 2009
March 2010   (final data collection date for primary outcome measure)
Incidence of new infections [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Incidence of new infections [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00943709 on ClinicalTrials.gov Archive Site
  • Number of episodes of infection [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Duration of neutropenia [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Number of days of bacteremia/fungemia [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Number of days of fever [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Duration of nutrition [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Duration of mucositis [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Duration of hospital stay [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Duration of antibiotic use [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Incidence of thromboembolic events [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Body weight changes [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Median survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Remission rate with induction or salvage chemotherapy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Number of episodes of infection [ Designated as safety issue: No ]
  • Duration of neutropenia [ Designated as safety issue: No ]
  • Number of days of bacteremia/fungemia [ Designated as safety issue: No ]
  • Number of days of fever [ Designated as safety issue: No ]
  • Duration of nutrition [ Designated as safety issue: No ]
  • Duration of mucositis [ Designated as safety issue: No ]
  • Duration of hospital stay [ Designated as safety issue: No ]
  • Duration of antibiotic use [ Designated as safety issue: No ]
  • Incidence of thromboembolic events [ Designated as safety issue: No ]
  • Body weight changes [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Remission rate with induction or salvage chemotherapy [ Designated as safety issue: No ]
  • Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Hyperglycemia
  • Leukemia
  • Biological: insulin glargine recombinant
    Given subcutaneously
  • Drug: therapeutic insulin
    Given subcutaneously
  • 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.
    Interventions:
    • Biological: insulin glargine recombinant
    • Drug: therapeutic insulin
  • 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.
    Interventions:
    • Biological: insulin glargine recombinant
    • Drug: therapeutic insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00943709
060601, AVENTIS-CINJ-060601, 0220070268, CDR0000648982, P30CA072720
Yes
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
  • National Cancer Institute (NCI)
  • Sanofi
Principal Investigator: Mecide Gharibo, MD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
August 2013

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