Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyperglycemia, Leukemia

Intervention / Treatment
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* Biological: insulin glargine recombinant
* Drug: therapeutic insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Biological: insulin glargine recombinant<br>* Given subcutaneously<br>Drug: therapeutic insulin<br>* Given subcutaneously<br>|
| Active Comparator: Arm II<br>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. | Biological: insulin glargine recombinant<br>* Given subcutaneously<br>Drug: therapeutic insulin<br>* Given subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new infections |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of infection |  | 4 years | 
| Duration of neutropenia |  | 4 years | 
| Number of days of bacteremia/fungemia |  | 4 years | 
| Number of days of fever |  | 4 years | 
| Duration of nutrition |  | 4 years | 
| Duration of mucositis |  | 4 years | 
| Duration of hospital stay |  | 4 years | 
| Duration of antibiotic use |  | 4 years | 
| Incidence of thromboembolic events |  | 4 years | 
| Body weight changes |  | 4 years | 
| Median survival |  | 4 years | 
| Remission rate with induction or salvage chemotherapy |  | 4 years | 
| Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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