NCT00943709

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 30, 2013

Status Verified

August 1, 2013

Enrollment Period

10 months

First QC Date

July 21, 2009

Last Update Submit

August 29, 2013

Conditions

HyperglycemiaLeukemia

Keywords

hyperglycemiarecurrent adult acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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 leukemiauntreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of new infections

    4 years

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

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 recombinantDrug: therapeutic insulin

Arm II

ACTIVE COMPARATOR

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 recombinantDrug: therapeutic insulin

Interventions

insulin glargine recombinantBIOLOGICAL

Given subcutaneously

Arm IArm II
therapeutic insulinDRUG

Given subcutaneously

Arm IArm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

HyperglycemiaLeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaCongenital AbnormalitiesLeukemia, Myeloid, Acute

Interventions

Insulin GlargineInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulin

Study Officials

  • Mecide Gharibo, MD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 22, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 30, 2013

Record last verified: 2013-08

Locations

US(1)