Clinical trial NCT00943709: Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
Official title: Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hyperglycemia
Leukemia
Keywords: 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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Sanofi
First posted: 2009-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of new infections
timeFrame: 4 years
Secondary outcomes:
measure: Number of episodes of infection
timeFrame: 4 years
measure: Duration of neutropenia
timeFrame: 4 years
measure: Number of days of bacteremia/fungemia
timeFrame: 4 years
measure: Number of days of fever
timeFrame: 4 years
measure: Duration of nutrition
timeFrame: 4 years
measure: Duration of mucositis
timeFrame: 4 years
measure: Duration of hospital stay
timeFrame: 4 years
measure: Duration of antibiotic use
timeFrame: 4 years
measure: Incidence of thromboembolic events
timeFrame: 4 years
measure: Body weight changes
timeFrame: 4 years
measure: Median survival
timeFrame: 4 years
measure: Remission rate with induction or salvage chemotherapy
timeFrame: 4 years
measure: Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring
timeFrame: 4 years
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Mecide Gharibo, MD
role: PRINCIPAL_INVESTIGATOR
References: