Trial · NCT03226418

Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia

NCT03226418, Phase 2, Completed, University of Nebraska; results first posted 2025-11-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia. Trials, record NCT03226418. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03226418

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia
NCT number: NCT03226418
Status: Completed
Phases: Phase 2
Enrollment: 75 participants, actual
Lead sponsor: University of Nebraska
Conditions: Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia
Interventions: Cytarabine, Decitabine, Idarubicin, Laboratory Biomarker Analysis, Liposome-encapsulated Daunorubicin-Cytarabine, Quality-of-Life Assessment, Questionnaire Administration, Azacitidine, Venetoclax, glasdegib
First posted: 2017-07-21
Last updated: 2026-03-10
Results first posted: 2025-11-05

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Rate of Complete Remission and Mortality in the Entire Cohort of Older Patients	At 90 days	All analyses will be performed based on intent-to-treat principle. The method of inversion will be used to generate an interval estimate for the proportion of 90-day mortality.
Secondary	Rate of Complete Remission (CR) or CR With Incomplete Count Recovery (CRi) and Mortality in Subsets of Older Patients Who Receive Intensive and Low-intensity Chemotherapy	At 90 days	All analyses will be performed based on intent-to-treat principle. The method of inversion will be used to generate an interval estimate for the proportion of 90-day mortality.
Secondary	Mortality at 90 Days	Up to 90 days from diagnosis	Mortality at 90 days will be calculated from date of diagnosis to date of death due to any cause within 90 days from diagnosis.
Secondary	To Asses the Impact of Treatment Intensity on Early Mortality in Older Patients, Who Receive Risk Stratified Therapy.	30 and 90 days	To asses the impact of treatment intensity on early mortality in older patients, who receive risk stratified therapy at 1-month and 3-month.
Secondary	To Determine Proportion of Patients With Impairments Detected by Geriatric Assessments.	Baseline	To determine proportion of patients with impairments detected by geriatric assessments (Hematopoietic Cell Transplantation Comorbidity Index score (HCL CI \>=3), Short Physical Performance Battery (SPPB=9or less), MoCA (Score of 25 or less), Activities of daily living, Instrumental activities of daily living, Depression screen (PHQ-9 \>= 10), nutritional screen (MNA\<=11)

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of Complete Remission and Mortality in the Entire Cohort of Older Patients	At 90 days	It was pre-specified to report for the entire cohort as a whole in this Outcome Measure. Results for each Arm/Group are pre-specified to be reported separately in Outcome Measure 2,	percentage of subjects	NUMBER
SECONDARY	Rate of Complete Remission (CR) or CR With Incomplete Count Recovery (CRi) and Mortality in Subsets of Older Patients Who Receive Intensive and Low-intensity Chemotherapy	At 90 days		percentage of participants	NUMBER
SECONDARY	Mortality at 90 Days	Up to 90 days from diagnosis		participants	NUMBER
SECONDARY	To Asses the Impact of Treatment Intensity on Early Mortality in Older Patients, Who Receive Risk Stratified Therapy.	30 and 90 days		percentage of participants	NUMBER
SECONDARY	To Determine Proportion of Patients With Impairments Detected by Geriatric Assessments.	Baseline		participants	NUMBER

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Rate of Complete Remission and Mortality in the Entire Cohort of Older Patients	Entire Cohort	90-Day Mortality	21.9	percentage of subjects
Rate of Complete Remission and Mortality in the Entire Cohort of Older Patients	Entire Cohort	Remission	52.0	percentage of subjects
Rate of Complete Remission (CR) or CR With Incomplete Count Recovery (CRi) and Mortality in Subsets of Older Patients Who Receive Intensive and Low-intensity Chemotherapy	Group I	90-Day CR/CRi	50	percentage of participants
Rate of Complete Remission (CR) or CR With Incomplete Count Recovery (CRi) and Mortality in Subsets of Older Patients Who Receive Intensive and Low-intensity Chemotherapy	Group II	90-Day CR/CRi	52.3	percentage of participants
Rate of Complete Remission (CR) or CR With Incomplete Count Recovery (CRi) and Mortality in Subsets of Older Patients Who Receive Intensive and Low-intensity Chemotherapy	Group I	90-Day Mortality	12.5	percentage of participants
Rate of Complete Remission (CR) or CR With Incomplete Count Recovery (CRi) and Mortality in Subsets of Older Patients Who Receive Intensive and Low-intensity Chemotherapy	Group II	90-Day Mortality	23.1	percentage of participants
Mortality at 90 Days	Group I		1	participants
Mortality at 90 Days	Group II		15	participants
To Asses the Impact of Treatment Intensity on Early Mortality in Older Patients, Who Receive Risk Stratified Therapy.	Group I	1 month	0	percentage of participants
To Asses the Impact of Treatment Intensity on Early Mortality in Older Patients, Who Receive Risk Stratified Therapy.	Group II	1 month	7.7	percentage of participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group I	8
Overall Study	STARTED	Group II	65
Overall Study	COMPLETED	Group I	8
Overall Study	COMPLETED	Group II	65
Overall Study	NOT COMPLETED	Group I	0
Overall Study	NOT COMPLETED	Group II	0

Source ClinicalTrials.gov

Adverse events80

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Group I	7	8	7
other	Anemia	Blood and lymphatic system disorders	Group II	65	65	65
other	Febrile neutropenia	Blood and lymphatic system disorders	Group I	7	8	7
other	Febrile neutropenia	Blood and lymphatic system disorders	Group II	65	65	65
other	Platelet count decreased	Blood and lymphatic system disorders	Group I	7	8	7
other	Platelet count decreased	Blood and lymphatic system disorders	Group II	65	65	65
other	Neutrophil count decreased	Blood and lymphatic system disorders	Group I	7	8	7
other	Neutrophil count decreased	Blood and lymphatic system disorders	Group II	63	65	63
other	White blood cell decreased	Blood and lymphatic system disorders	Group I	0	8	0
other	White blood cell decreased	Blood and lymphatic system disorders	Group II	4	65	4

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group I	1	8
Total, all-cause mortality	Group II	15	65
Total, other adverse events	Group I	7	8
Total, other adverse events	Group II	65	65
Total, serious adverse events	Group I	5	8
Total, serious adverse events	Group II	41	65

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35450817	DERIVED	PubMed
38000343	DERIVED	PubMed
40298352	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA036727	Buffett Cancer Center Support Grant	SWEASY, JOANN B.	UNIVERSITY OF NEBRASKA MEDICAL CENTER	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Group I vs Group II: Mortality at 90 Days	Trial comparisons
Group I vs Group II: deaths from any cause	Trial comparisons
Group I vs Group II: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03226418

GET https://conductscience.org/api/trials/v1/NCT03226418/results?page=2

API reference For AI assistants