Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443300
Status:
TERMINATED
Last Update Posted:
2012-08-02
First Post:
2007-03-01
Brief Title:
Effectiveness of Protected Environment Rooms for AML and MDS
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None