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Effectiveness of HEPA-filtered Rooms ("Protected Environment") to Prevent Morbidity and Mortality in Patients Age >/ = 60 Receiving Lower Intensity ("Targeted") Therapy for Untreated AML and High-risk Myelodysplasia (MDS)


N/A
60 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

Effectiveness of HEPA-filtered Rooms ("Protected Environment") to Prevent Morbidity and Mortality in Patients Age >/ = 60 Receiving Lower Intensity ("Targeted") Therapy for Untreated AML and High-risk Myelodysplasia (MDS)


For AML or high-risk MDS, it has been common practice for patients aged 50 and older to
receive initial treatment in the PE at M. D. Anderson. The PE is a series of rooms
containing a special air-flow system that is designed to filter out germs that can cause
serious infection. Patients stay in a PE room, without leaving, for up to 5 weeks. In an
attempt to keep a PE room germ-free, only the medical staff is allowed in the room. Family
and visitors can see the patient, but are separated from the patient by a glass wall. Each
PE room has a laptop computer that can be connected to the internet. Books, newspapers, and
various other materials are only allowed in the PE room after they have been sterilized for
safety reasons.

Therapy given to patients with AML or MDS has recently changed from higher (which usually
meant that there was more possibility for infections and a need for hospitalization) to
lower intensity. Because the value of the PE was already established in patients receiving
higher-intensity therapy, researchers want to learn about the value of the PE in patients
receiving lower-intensity therapy.

If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 groups. You will have an equal chance of being in either one of the groups.
Participants in one group will be placed in the PE. Participants in the other group will
not be placed in the PE but will have outpatient care. After the first 30 participants have
been assigned to one group or the other, the chances of future participants being assigned
to the PE will depend on the results (rates of infection) seen in earlier participants.

If you are assigned to the PE, you will stay in the PE for 5 weeks after beginning your
standard treatment. You will be removed from the PE if medical problems develop that
require you to receive treatment somewhere else in the hospital or if staying in the PE is
simply too difficult (such as because of claustrophobia [fear of being in a closed space] or
because of a feeling of "home sickness" [a strong desire to have physical contact with
family and friends]).

If you are not assigned to the PE, you will be asked to stay in Houston for 5 weeks and will
receive treatment on an outpatient basis, unless you have problems that require
hospitalization (not in the PE).

You may choose not to be assigned to either group. If this is the case, the study doctor or
study staff will ask you to participate in this study through allowing your data
(information) to be collected.

If you choose not to be assigned and you agree, study staff will collect data regarding your
rates of infections and remission (inactive disease) and the status of your health over time
so that this information can be compared with rates seen in patients who took part in 1 of
the 2 groups. This comparison information will be used to learn the value of the PE in
patients receiving lower-intensity therapy. Up to 125 patients will take part in this
study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



- 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

Exclusion Criteria:

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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Success Rate

Outcome Description:

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.

Outcome Time Frame:

Baseline to 6 weeks post randomization to PE or Non PE

Safety Issue:

No

Principal Investigator

Gloria N. Mattiuzzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas MD. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0696

NCT ID:

NCT00443300

Start Date:

January 2007

Completion Date:

January 2008

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • AML
  • MDS
  • Protected Environment
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030