Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Conditions
Brief 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).
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.
Interventions
None listed
Sponsors
Patient-Centered Outcomes Research Institute
American Cancer Society, Inc.
Fred Hutchinson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT) | 1 year after starting induction | Percentage analyzed participants receiving HCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Analyzed Participants Without HCT and Deceased | 1 year after starting induction | Percentage analyzed participants without HCT and Deceased |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease. | 703 |
| Total | 703 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | received HCT as initial treatment | 8 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 267 Participants |
| Age, Categorical Between 18 and 65 years | 436 Participants |
| Age, Continuous | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 662 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 13 Participants |
| Race (NIH/OMB) Asian | 23 Participants |
| Race (NIH/OMB) Black or African American | 41 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 608 Participants |
| Region of Enrollment United States | 703 participants |
| Sex: Female, Male Female | 304 Participants |
| Sex: Female, Male Male | 399 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 309 / 695 |
| other Total, other adverse events | 0 / 695 |
| serious Total, serious adverse events | 0 / 695 |
Outcome results
Primary
Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)
Percentage analyzed participants receiving HCT
Time frame: 1 year after starting induction
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT) | 44.7 % participants |
Secondary
Percentage Analyzed Participants Without HCT and Deceased
Percentage analyzed participants without HCT and Deceased
Time frame: 1 year after starting induction
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Percentage Analyzed Participants Without HCT and Deceased | 32.7 % participants |