Status:
WITHDRAWN
Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Sanofi
Conditions:
Hyperglycemia
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 random...
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00943709
Start Date
May 1 2009
End Date
March 1 2010
Last Update
August 30 2013
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903