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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00943709
Other study ID # 060601
Secondary ID AVENTIS-CINJ-060
Status Withdrawn
Phase Phase 3
First received July 21, 2009
Last updated August 29, 2013
Start date May 2009
Est. completion date March 2010

Study information

Verified date August 2013
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Biological:
insulin glargine recombinant
Given subcutaneously
Drug:
therapeutic insulin
Given subcutaneously

Locations

Country Name City State
United States Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey

Sponsors (3)

Lead Sponsor Collaborator
University of Medicine and Dentistry of New Jersey National Cancer Institute (NCI), Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of new infections 4 years No
Secondary Number of episodes of infection 4 years No
Secondary Duration of neutropenia 4 years No
Secondary Number of days of bacteremia/fungemia 4 years No
Secondary Number of days of fever 4 years No
Secondary Duration of nutrition 4 years No
Secondary Duration of mucositis 4 years No
Secondary Duration of hospital stay 4 years No
Secondary Duration of antibiotic use 4 years No
Secondary Incidence of thromboembolic events 4 years No
Secondary Body weight changes 4 years No
Secondary Median survival 4 years No
Secondary Remission rate with induction or salvage chemotherapy 4 years No
Secondary Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring 4 years No
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