Hyperglycemia, Leukemia
Conditions
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
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.
Interventions
BIOLOGICALinsulin glargine recombinant
Given subcutaneously
DRUGtherapeutic insulin
Given subcutaneously
Sponsors
National Cancer Institute (NCI)
Sanofi
University of Medicine and Dentistry of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of new infections | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of episodes of infection | 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 |
| Duration of antibiotic use | 4 years |
Countries
United States
Outcome results
None listed