Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

Leukemia Clinical Trial

Official title: Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperglycemia
• Leukemia

• NCT number: NCT00943709
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 2009
• Completion date: March 2010