Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

University of Medicine and Dentistry of New Jersey

Status and phase: Withdrawn; Phase 3

Conditions: Hyperglycemia; Leukemia

Treatments: Drug: therapeutic insulin; Biological: insulin glargine recombinant

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00943709

060601

P30CA072720 (U.S. NIH Grant/Contract)

0220070268 (Other Identifier)

AVENTIS-CINJ-060601

CDR0000648982

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm I

Experimental group

Description:

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.

Treatment:

Biological: insulin glargine recombinant

Drug: therapeutic insulin

Arm II

Active Comparator group

Description:

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.

Treatment:

Biological: insulin glargine recombinant

Drug: therapeutic insulin