N/A
Completed N=703
Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients
leukemia · Myelodysplastic Syndrome (MDS)
Source: ClinicalTrials.gov NCT01929408 ↗
Enrolled (actual)
703
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT) — 44.7 % participants
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).
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 | — |
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. Informational only — not medical advice.