Acute Myeloid Leukemia (AML)NCT01929408
Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients
An observational study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Fred Hutchinson Cancer Center at 12 sites in United States.
Trial summary
The purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
- How many people
- 703 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Jul 2013to 4 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include non-M3 AML (including first relapsed and primary refractory AML) and high-risk MDS, MPN, and MF adult patients considered for chemotherapy at FHCRC and the Seattle Cancer Care Alliance Network and other Core institutions (Stanford School of Medicine, Cleveland Clinic, Northwestern University, University of Utah, University of Pennsylvania, Washington University in St. Louis, Roswell Park Cancer Institute, Hackensack University, University of Maryland, and Duke University).
Who may be able to join
- Patients with new diagnoses of non-M3 AML or high-risk MDS, myeloproliferative neoplasms (MPN), or myelofibrosis (MF) (showing 10% or more blasts in bone marrow) who:
- Present for an AML-like treatment that could plausibly produce a complete remission (CR); for example intensive induction chemotherapy, low dose single agent chemotherapy, hypomethylation agent, or a similar therapy
- Possibility to retrieve follow-up records from the collaborating institution or treating primary care physician
- Patients with primary refractory or first relapse presenting for salvage chemotherapy will be allowed
- Patients of 18 years of age or older, and are being treated by the adult AML service.
- Able to speak and read English.
- Willing and able to provide informed consent.
Who cannot join
- Patients of ≤17 years of age or who are 18 or older and receive treatment under the pediatric AML service.
- Patients older than 80 years
- Patients with <6 months projected survival due to active second malignancy or other medical problem.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Maryland
Baltimore, Maryland, 21201
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27710
The John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
SCCA Network Clinics
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Cancer Institute
Stanford, California, 94305
About this study
Official title: Feasibility and Outcomes of Allogeneic Hematopoietic Cell Transplantation (HCT) Compared to Conventional Therapy for Older and Medically Infirm Patients Diagnosed With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes: A Prospective Observational Study
The purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Read the detailed description
This is a prospective multicenter observational study in a Consortium of collaborating institutions investigating how often older and medically infirm patients who are diagnosed with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndromes (MDS) and treated with induction chemotherapy undergo allogeneic HCT. Investigators will look at the rate of undergoing allogeneic HCT among older and medically infirm AML and high-risk MDS patients compared to younger and relatively healthier patients. Investigators will also compare the characteristics and outcomes of patients who did versus did not proceed to allogeneic HCT. A number of outcomes will be assessed including mortality, morbidity, and quality of life (QOL). Baseline information will be collected on different domains of QOL, geriatric assessment, health status measures, AML features, and socioeconomic status. Information will help physicians and patients to decide on best treatment choices for AML and high-risk MDS in older and medically infirm patients.
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)
Percentage analyzed participants receiving HCT
Measured: 1 year after starting induction
Secondary outcomes (1)
Percentage Analyzed Participants Without HCT and Deceased
Percentage analyzed participants without HCT and Deceased
Measured: 1 year after starting induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study start19 Jul 2013
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Fred Hutchinson 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Mohamed Sorror, MD, MSc, Principal investigator, Associate Member, Fred Hutch; Associate Professor of Medicine, UW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929408
- Sponsor's protocol ID
- 2368.00
- Other IDs
- RSG-13-084-01-CPHPS
- Status last verified
- Nov 2019
- First submitted
- 14 Aug 2013
- Last updated
- 15 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sorror ML, Gooley TA, Storer BE, Gerds AT, Sekeres MA, Medeiros BC, Wang ES, Shami PJ, Adekola K, Luger S, Baer MR, Rizzieri DA, Wildes TM, Koprivnikar J, Smith J, Garrison M, Kojouri K, Schuler TA, Leisenring WM, Onstad LE, Becker PS, McCune JS, Lee SJ, Sandmaier BM, Appelbaum FR, Estey EH. An 8-year pragmatic observation evaluation of the benefits of allogeneic HCT in older and medically infirm patients with AML. Blood. 2023 Jan 19;141(3):295-308. doi: 10.1182/blood.2022016916.
PubMed 36260765Sorror ML, Storer BE, Fathi AT, Brunner A, Gerds AT, Sekeres MA, Mukherjee S, Medeiros BC, Wang ES, Vachhani P, Shami PJ, Pena E, Elsawy M, Adekola K, Luger S, Baer MR, Rizzieri D, Wildes TM, Koprivnikar J, Smith J, Garrison M, Kojouri K, Leisenring W, Onstad L, Nyland JE, Becker PS, McCune JS, Lee SJ, Sandmaier BM, Appelbaum FR, Estey EH. Multisite 11-year experience of less-intensive vs intensive therapies in acute myeloid leukemia. Blood. 2021 Aug 5;138(5):387-400. doi: 10.1182/blood.2020008812.
PubMed 34351368
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Outcomes of Allogeneic Hematopoietic Cell Transplantation (HCT) Compared to Conventional Therapy for Older and Medically Infirm Patients Diagnosed With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01929408
- Acronym / sponsor ID
- 2368.00
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American Cancer Society, Inc.
- Study start
- 19 Jul 2013 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Posted 15 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Detailed description
This is a prospective multicenter observational study in a Consortium of collaborating institutions investigating how often older and medically infirm patients who are diagnosed with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndromes (MDS) and treated with induction chemotherapy undergo allogeneic HCT. Investigators will look at the rate of undergoing allogeneic HCT among older and medically infirm AML and high-risk MDS patients compared to younger and relatively healthier patients. Investigators will also compare the characteristics and outcomes of patients who did versus did not proceed to allogeneic HCT. A number of outcomes will be assessed including mortality, morbidity, and quality of life (QOL). Baseline information will be collected on different domains of QOL, geriatric assessment, health status measures, AML features, and socioeconomic status. Information will help physicians and patients to decide on best treatment choices for AML and high-risk MDS in older and medically infirm patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include non-M3 AML (including first relapsed and primary refractory AML) and high-risk MDS, MPN, and MF adult patients considered for chemotherapy at FHCRC and the Seattle Cancer Care Alliance Network and other Core institutions (Stanford School of Medicine, Cleveland Clinic, Northwestern University, University of Utah, University of Pennsylvania, Washington University in St. Louis, Roswell Park Cancer Institute, Hackensack University, University of Maryland, and Duke University).
Key inclusion criteria (7 listed)
- Patients with new diagnoses of non-M3 AML or high-risk MDS, myeloproliferative neoplasms (MPN), or myelofibrosis (MF) (showing 10% or more blasts in bone marrow) who:
- Present for an AML-like treatment that could plausibly produce a complete remission (CR); for example intensive induction chemotherapy, low dose single agent chemotherapy, hypomethylation agent, or a similar therapy
- Possibility to retrieve follow-up records from the collaborating institution or treating primary care physician
- Patients with primary refractory or first relapse presenting for salvage chemotherapy will be allowed
- Patients of 18 years of age or older, and are being treated by the adult AML service.
Key exclusion criteria (3 listed)
- Patients of ≤17 years of age or who are 18 or older and receive treatment under the pediatric AML service.
- Patients older than 80 years
- Patients with <6 months projected survival due to active second malignancy or other medical problem.
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
Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)
Time frame: 1 year after starting induction
Percentage analyzed participants receiving HCT
1 secondary outcome
Percentage Analyzed Participants Without HCT and Deceased
Time frame: 1 year after starting induction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36260765Sorror ML, Gooley TA, Storer BE, Gerds AT, Sekeres MA, Medeiros BC, Wang ES, Shami PJ, Adekola K, Luger S, Baer MR, Rizzieri DA, Wildes TM, Koprivnikar J, Smith J, Garrison M, Kojouri K, Schuler TA, Leisenring WM, Onstad LE, Becker PS, McCune JS, Lee SJ, Sandmaier BM, Appelbaum FR, Estey EH. An 8-year pragmatic observation evaluation of the benefits of allogeneic HCT in older and medically infirm patients with AML. Blood. 2023 Jan 19;141(3):295-308. doi: 10.1182/blood.2022016916.
- Derived from this study: PubMed 34351368Sorror ML, Storer BE, Fathi AT, Brunner A, Gerds AT, Sekeres MA, Mukherjee S, Medeiros BC, Wang ES, Vachhani P, Shami PJ, Pena E, Elsawy M, Adekola K, Luger S, Baer MR, Rizzieri D, Wildes TM, Koprivnikar J, Smith J, Garrison M, Kojouri K, Leisenring W, Onstad L, Nyland JE, Becker PS, McCune JS, Lee SJ, Sandmaier BM, Appelbaum FR, Estey EH. Multisite 11-year experience of less-intensive vs intensive therapies in acute myeloid leukemia. Blood. 2021 Aug 5;138(5):387-400. doi: 10.1182/blood.2020008812.
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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.
Mohamed Sorror, MD, MSc principal investigator
Associate Member, Fred Hutch; Associate Professor of Medicine, UW
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Fred Hutchinson Cancer Center at 12 sites 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 7 inclusion and 3 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 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Yes. Results are posted in the registry (first posted 15 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT) (time frame: 1 year after starting induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01929408, which also lists 2 linked publications.
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 15 Nov 2019.