NCT00443300

Brief Summary

The goal of this clinical research study is to learn if the "protected environment" (PE) can help to prevent infections in patients aged 60 and above who are receiving what is considered low-intensity treatment for newly-diagnosed AML or high-risk MDS.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

March 1, 2007

Last Update Submit

August 1, 2012

Conditions

Acute Myelogenous LeukemiaMyelodysplastic Syndrome

Keywords

AMLMDSProtected Environment

Outcome Measures

Primary Outcomes (1)

  • Success Rate

    Success is defined as number of participants with no death, pneumonia, or sepsis within 6 weeks of randomization compared to total number of participants to evaluate effect of the protected environment (PE) by (adaptively) randomly assigning patients age \>/= 60 given targeted therapies between treatment inside or outside the PE.

    Baseline to 6 weeks post randomization to PE or Non PE

Study Arms (2)

Protective environment

Participants in a Protective environment

Not a protective environment

Participants not in a protective environment

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with AML or high-risk MDS Age \>/= 60 years with a Zubrod performance status of 0,1, or 2

You may qualify if:

  • AML or high-risk MDS (\> 10% blasts in the marrow or blood)
  • Patient is to be given "targeted therapy". Examples of targeted therapies are tipifarnib + low-dose ara-C, decitabine, and 5 azacitidine + valproic acid.
  • Age \>/= 60 years and Zubrod performance status of 0,1, or 2
  • Informed consent obtained

You may not qualify if:

  • Cannot receive ara-C at a dose \>/= 100 mg/m2 daily, anthracyclines, or cloretazine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Officials

  • Gloria N. Mattiuzzi, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 5, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

US(1)