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


Phase 3
18 Years
N/A
Not Enrolling
Both
Hyperglycemia, Leukemia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of new infections

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Mecide Gharibo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Institutional Review Board

Study ID:

CDR0000648982

NCT ID:

NCT00943709

Start Date:

May 2009

Completion Date:

March 2010

Related Keywords:

  • Hyperglycemia
  • Leukemia
  • 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
  • Hyperglycemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

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