Acute Myelogenous LeukemiaNCT00443300
Effectiveness of Protected Environment Rooms for AML and MDS
An observational study of Acute Myelogenous Leukemia and Myelodysplastic Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Myelodysplastic Syndrome
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AML or high-risk MDS Age >/= 60 years with a Zubrod performance status of 0,1, or 2
Who may be able to join
- 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
Who cannot join
- Cannot receive ara-C at a dose >/= 100 mg/m2 daily, anthracyclines, or cloretazine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the detailed description
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.
- Keywords
- AML, MDS, Protected Environment
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Protective environment | Participants in a Protective environment | |
| Not a protective environment | Participants not in a protective environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 weeks post randomization to PE or Non PE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: Terminated due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gloria N. Mattiuzzi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443300
- Sponsor's protocol ID
- 2006-0696
- Status last verified
- Aug 2012
- First submitted
- 1 Mar 2007
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00443300
- Acronym / sponsor ID
- 2006-0696
- Keywords
- AML, MDS, Protected Environment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 5 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protective environment | – | –Participants in a Protective environment |
| Not a protective environment | – | –Participants not in a protective environment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AML or high-risk MDS Age >/= 60 years with a Zubrod performance status of 0,1, or 2
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Cannot receive ara-C at a dose >/= 100 mg/m2 daily, anthracyclines, or cloretazine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success Rate
Time frame: Baseline to 6 weeks post randomization to PE or Non PE
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.
Results and safety
The study was stopped early (reason given: Terminated due to low accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- M.D. Anderson's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria N. Mattiuzzi, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myelogenous Leukemia and Myelodysplastic Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to low accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: Baseline to 6 weeks post randomization to PE or Non PE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.