Acute Myelogenous LeukemiaNCT00459524
Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (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
Primary Objectives: To compare the neuropsychiatric (NP) and neurocognitive (NC) symptoms and assess the quality of life (QOL) in older patients (age > 18) with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) receiving different therapies, chemotherapy (Clofarabine + ara-C) or targeted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Questionnaire and Neurocognitive Testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with acute myelogenous leukemia or myelodysplastic syndrome.
Who may be able to join
- Patients with newly diagnosed AML or MDS. Patients who fail an MDS/AML therapy and receive other therapies may be asked to continue participation in this neurocognitive study.
- Patients who are 18 years of age or older.
- Patients who are seen in the MDACC adult Leukemia clinic. Patients who do not enroll onto therapy protocols are also eligible.
- Patients must sign the informed consent.
Who cannot join
- 1) Not applicable
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Longitudinal Assessment of Neurocognitive Function and Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Undergoing Treatment
Primary Objectives:
- To compare the neuropsychiatric (NP) and neurocognitive (NC) symptoms and assess the quality of life (QOL) in older patients (age > 18) with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) receiving different therapies, chemotherapy (Clofarabine + ara-C) or targeted therapies (PKC412 + low-dose ara-C, or R115777 + low-dose ara-C, or decitabine, or STI + low-dose ara-C).
- To determine whether there is a correlation between the number of packed red blood cell (PRBC) transfusions and cognitive scores and/or QOL.
Read the detailed description
You will participate in a series of neurocognitive tests. For these tests, you will be asked to complete certain tasks that require the use of your hands, eyes, and ears. The neurocognitive testing will take about 30 minutes.
You will answer some questionnaires about disease symptoms and your quality of life. It will take about 30 minutes to complete the questionnaires.
You will participate in these neurocognitive tests and fill out the questionnaires before you begin cancer therapy. Your interval testing will coincide with your clinic visit evaluations, which will be approximately at 1 month, 3 months, and 6 months. If you do not receive therapy, you will be asked to complete the neurocognitive tests at baseline and then again on your follow up clinic visit evaluations, which will be approximately at 3 months and at 6 months. You may be asked to continue your participation in these neurocognitive tests and fill out questionnaires approximately every 3 months thereafter.
This is an investigational study. About 306 patients will take part in this study. All will be enrolled at UTMDACC.
- Being tested
- Questionnaire, Neurocognitive Testing
- Keywords
- Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia, Quality of Life, Questionnaire, Survey, Neurocognitive Function, AML, MDS, QOL
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking about 30 minutes to complete.
Neurocognitive TestingBehavioural
Neurocognitive testing lasting 30 minutes. Patients will be asked to complete certain tasks that require the use of their hands, eyes, and ears.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | AML and MDS Patients Receives: Behavioral: Questionnaire; Behavioral: Neurocognitive Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of cancer therapy on AML or MDS patients (longitudinal assessment neuropsychiatric (NP), neurocognitive (NC) symptoms, quality of life (QOL))
Measured: Interval testing will be approximately at 1 month, 3 months, and 6 months.
Secondary outcomes (1)
Effects of therapy on the ability to think, quality of life, the ability to perform everyday tasks, and how often side effects occur.
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startApr 2004
- Primary completionMar 2009
- Study completionMar 2009
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 only
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina A. Meyers, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459524
- Sponsor's protocol ID
- 2004-0060
- Status last verified
- Jul 2012
- First submitted
- 11 Apr 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Neurocognitive Function and Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Undergoing Treatment
- ClinicalTrials.gov ID
- NCT00459524
- Acronym / sponsor ID
- 2004-0060
- Keywords
- Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia, Quality of Life, Questionnaire, Survey, Neurocognitive Function, AML
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Apr 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.
Primary Objectives:
- To compare the neuropsychiatric (NP) and neurocognitive (NC) symptoms and assess the quality of life (QOL) in older patients (age > 18) with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) receiving different therapies, chemotherapy (Clofarabine + ara-C) or targeted therapies (PKC412 + low-dose ara-C, or R115777 + low-dose ara-C, or decitabine, or STI + low-dose ara-C).
- To determine whether there is a correlation between the number of packed red blood cell (PRBC) transfusions and cognitive scores and/or QOL.
Detailed description
You will participate in a series of neurocognitive tests. For these tests, you will be asked to complete certain tasks that require the use of your hands, eyes, and ears. The neurocognitive testing will take about 30 minutes.
You will answer some questionnaires about disease symptoms and your quality of life. It will take about 30 minutes to complete the questionnaires.
You will participate in these neurocognitive tests and fill out the questionnaires before you begin cancer therapy. Your interval testing will coincide with your clinic visit evaluations, which will be approximately at 1 month, 3 months, and 6 months. If you do not receive therapy, you will be asked to complete the neurocognitive tests at baseline and then again on your follow up clinic visit evaluations, which will be approximately at 3 months and at 6 months. You may be asked to continue your participation in these neurocognitive tests and fill out questionnaires approximately every 3 months thereafter.
This is an investigational study. About 306 patients will take part in this study. All will be enrolled at UTMDACC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Behavioral: Questionnaire, Behavioral: Neurocognitive TestingAML and MDS Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with acute myelogenous leukemia or myelodysplastic syndrome.
Key inclusion criteria (4 listed)
- Patients with newly diagnosed AML or MDS. Patients who fail an MDS/AML therapy and receive other therapies may be asked to continue participation in this neurocognitive study.
- Patients who are 18 years of age or older.
- Patients who are seen in the MDACC adult Leukemia clinic. Patients who do not enroll onto therapy protocols are also eligible.
- Patients must sign the informed consent.
Key exclusion criteria (1 listed)
- 1) Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires taking about 30 minutes to complete. | Behavioural | Questionnaire |
| Neurocognitive TestingNeurocognitive testing lasting 30 minutes. Patients will be asked to complete certain tasks that require the use of their hands, eyes, and ears. | Behavioural | Questionnaire |
Primary outcome
Effect of cancer therapy on AML or MDS patients (longitudinal assessment neuropsychiatric (NP), neurocognitive (NC) symptoms, quality of life (QOL))
Time frame: Interval testing will be approximately at 1 month, 3 months, and 6 months.
1 secondary outcome
Effects of therapy on the ability to think, quality of life, the ability to perform everyday tasks, and how often side effects occur.
Time frame: 6 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Acute Myelogenous Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Christina A. Meyers, PhD 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: finished, as of the sponsor's last update on 1 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of cancer therapy on AML or MDS patients (longitudinal assessment neuropsychiatric (NP), neurocognitive (NC) symptoms, quality of life (QOL)) (time frame: Interval testing will be approximately at 1 month, 3 months, and 6 months.). 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 1 Aug 2012.