Clinical trial · Observational
Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients
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
NCT01929408CI-TRIAL-00041656completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)
- timeFrame
- 1 year after starting induction
- description
- Percentage analyzed participants receiving HCT
Secondary outcomes (1)
- measure
- Percentage Analyzed Participants Without HCT and Deceased
- timeFrame
- 1 year after starting induction
- description
- Percentage analyzed participants without HCT and Deceased
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDSorror 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. PMID 36260765
- DERIVEDSorror 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. PMID 34351368