Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

• Status: Withdrawn
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborators: National Cancer Institute (NCI); Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

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