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.

Study Overview

• Status: Withdrawn
• Conditions: Hyperglycemia; Leukemia
• Intervention / Treatment: Biological: insulin glargine recombinant; Drug: therapeutic insulin

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of new infections	4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of episodes of infection	4 years
Duration of neutropenia	4 years
Number of days of bacteremia/fungemia	4 years
Number of days of fever	4 years
Duration of nutrition	4 years
Duration of mucositis	4 years
Duration of hospital stay	4 years
Duration of antibiotic use	4 years
Incidence of thromboembolic events	4 years
Body weight changes	4 years
Median survival	4 years
Remission rate with induction or salvage chemotherapy	4 years
Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring	4 years

Collaborators and Investigators

• Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: National Cancer Institute (NCI); Sanofi
• Investigators: Principal Investigator: Mecide Gharibo, MD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 21, 2009
• First Posted (Estimate): July 22, 2009

Study Record Updates

• Last Update Posted (Estimate): August 30, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: 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; hyperglycemia; recurrent adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms by Histologic Type; Neoplasms; Hyperglycemia; Leukemia; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: 060601; P30CA072720 (U.S. NIH Grant/Contract); AVENTIS-CINJ-060601; 0220070268 (Other Identifier: IRB Number); CDR0000648982