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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Hyperglycemia
Leukemia
Biological: insulin glargine recombinant
Drug: therapeutic insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Incidence of new infections [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943709

Locations
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
Sanofi
Investigators
Principal Investigator: Mecide Gharibo, MD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00943709     History of Changes
Other Study ID Numbers: 060601, AVENTIS-CINJ-060601, 0220070268, CDR0000648982, P30CA072720
Study First Received: July 21, 2009
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rutgers, The State University 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:
Hyperglycemia
Leukemia
Glucose Metabolism Disorders
Metabolic Diseases
Neoplasms
Neoplasms by Histologic Type
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014