N/A
N=703
Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients
Acute Myeloid Leukemia (AML) · Myelodysplastic Syndrome (MDS)
Bottom Line
View on ClinicalTrials.gov: NCT01929408 ↗Enrolled (actual)
703
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT) — 44.7 % participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT) |
44.7 | — |
| SECONDARY Percentage Analyzed Participants Without HCT and Deceased |
32.7 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01929408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.