Trial · NCT03701308

Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

NCT03701308, Phase 2, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2026-01-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy. Trials, record NCT03701308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03701308

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Trial

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

Title: Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy
NCT number: NCT03701308
Status: Active not recruiting
Phases: Phase 2, Phase 3
Enrollment: 267 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Acute Myeloid Leukemia
Interventions: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Cytarabine, Daunorubicin, Echocardiography Test, Multigated Acquisition Scan, Uproleselan
First posted: 2018-10-10
Last updated: 2026-01-21
Results first posted: 2026-01-21

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Event-free Survival (EFS)	67 months	EFS is defined as the time from the date of randomization to the first of failure to achieve a complete remission (CR)/ CR with incomplete blood count recovery (CRi) during induction, relapse, or death due to any cause, with patients last known to be alive and event-free censored at the date of last contact.
Primary	Overall Survival (OS)	67 months	Will be measured from the date of randomization to death from any cause, with patients last known to be alive censored at the date of last contact.
Secondary	EFS Rate at 24 Months	24 months	Event Free Survival will be defined as the time from patient registration to treatment failure, progression, or death. The proportion of patients alive and event free at 24 months will be reported.
Secondary	Impact of Off-protocol Transplantation	Up to 5 years	Sensitivity analyses will be conducted. In addition, the proportion of patients who received transplantation in the two arms will be summarized and compared using a chi-square test.
Secondary	Consistency of the Treatment Effect Among Each Subgroup	From baseline up to 5 years	Non-parametric methods such as Kaplan-Meier and log-rank tests will be used within each subgroup. Univariate/multivariate Cox models will be fit within each subgroups; hazard ratios will be used to quantify the treatment effect within each subgroup, along with the 95% confidence intervals.
Secondary	Disease-free Survival (DFS)	Time from achieving a complete response to time of relapse or death, assessed up to 5 years
Secondary	Complete Remission (CR) and Overall Response Rate	Up to 5 years
Secondary	Incidence of Adverse Events	Up to 5 years	Will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 5.0. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Secondary	Prediction of CR, EFS, DFS, and OS by Pretreatment Characteristics Such as Age, Morphology, Cytogenetics, Immunophenotype, Molecular Genetic Features, WBC Count and Hemogram, and Performance Status With Clinical Outcomes	Up to 5 years	The associations between these baseline factors and CR, EFS, DFS, and OS will be analyzed using Kaplan-Meier curves, log-rank test, contingency table and chi-square test whenever appropriate. Multivariable analysis including Cox proportional hazards models and logistic regression models will be used as well to evaluate the associations.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-free Survival (EFS)	67 months		months	MEDIAN
PRIMARY	Overall Survival (OS)	67 months	All registered patients	Months	MEDIAN
SECONDARY	EFS Rate at 24 Months	24 months	All eligible patients	proportion of patients	NUMBER
SECONDARY	Impact of Off-protocol Transplantation	Up to 5 years
SECONDARY	Consistency of the Treatment Effect Among Each Subgroup	From baseline up to 5 years
SECONDARY	Disease-free Survival (DFS)	Time from achieving a complete response to time of relapse or death, assessed up to 5 years
SECONDARY	Complete Remission (CR) and Overall Response Rate	Up to 5 years
SECONDARY	Incidence of Adverse Events	Up to 5 years
SECONDARY	Prediction of CR, EFS, DFS, and OS by Pretreatment Characteristics Such as Age, Morphology, Cytogenetics, Immunophenotype, Molecular Genetic Features, WBC Count and Hemogram, and Performance Status With Clinical Outcomes	Up to 5 years

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Event-free Survival (EFS)	Arm I (Daunorubicin, Cytarabine)	5.4	95% Confidence Interval 3.3 to 8.3	months
Event-free Survival (EFS)	Arm II (Uproleselan, Daunorubicin, Cytarabine)	9.4	95% Confidence Interval 5.2 to 13.8	months
Overall Survival (OS)	Arm I (Daunorubicin, Cytarabine)	19.8	95% Confidence Interval 14.6 to 43.3	Months
Overall Survival (OS)	Arm II (Uproleselan, Daunorubicin, Cytarabine)	23.6	95% Confidence Interval 15.1 to 35.3	Months
EFS Rate at 24 Months	Arm I (Daunorubicin, Cytarabine)	0.290	95% Confidence Interval 0.215 to 0.390	proportion of patients
EFS Rate at 24 Months	Arm II (Uproleselan, Daunorubicin, Cytarabine)	0.326	95% Confidence Interval 0.249 to 0.426	proportion of patients

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Daunorubicin, Cytarabine)	136
Overall Study	STARTED	Arm II (Uproleselan, Daunorubicin, Cytarabine)	131
Overall Study	COMPLETED	Arm I (Daunorubicin, Cytarabine)	134
Overall Study	COMPLETED	Arm II (Uproleselan, Daunorubicin, Cytarabine)	129
Overall Study	NOT COMPLETED	Arm I (Daunorubicin, Cytarabine)	2
Overall Study	NOT COMPLETED	Arm II (Uproleselan, Daunorubicin, Cytarabine)	2

Source ClinicalTrials.gov

Adverse events592

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	Arm I (Daunorubicin, Cytarabine)	99	136	359
other	Anemia	Blood and lymphatic system disorders	Arm II (Uproleselan, Daunorubicin, Cytarabine)	103	131	405
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	Arm I (Daunorubicin, Cytarabine)	3	136	4
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	Arm II (Uproleselan, Daunorubicin, Cytarabine)	2	131	9
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Arm I (Daunorubicin, Cytarabine)	2	136	2
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Arm II (Uproleselan, Daunorubicin, Cytarabine)	1	131	1
other	Eosinophilia	Blood and lymphatic system disorders	Arm I (Daunorubicin, Cytarabine)	0	136	0
other	Eosinophilia	Blood and lymphatic system disorders	Arm II (Uproleselan, Daunorubicin, Cytarabine)	1	131	1
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm I (Daunorubicin, Cytarabine)	107	136	137
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm II (Uproleselan, Daunorubicin, Cytarabine)	95	131	149

1 to 10 of 592Source ClinicalTrials.gov

See all 592 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Daunorubicin, Cytarabine)	47	136
Total, all-cause mortality	Arm II (Uproleselan, Daunorubicin, Cytarabine)	84	131
Total, other adverse events	Arm I (Daunorubicin, Cytarabine)	130	136
Total, other adverse events	Arm II (Uproleselan, Daunorubicin, Cytarabine)	126	131
Total, serious adverse events	Arm I (Daunorubicin, Cytarabine)	12	136
Total, serious adverse events	Arm II (Uproleselan, Daunorubicin, Cytarabine)	12	131

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
U10CA180821	Alliance for Clinical Trials in Oncology Operations Center	Galanis, Evanthia; Hahn, Olwen; Kozono, David	ALLIANCE NCTN FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Arm I (Daunorubicin, Cytarabine) vs Arm II (Uproleselan, Daunorubicin, Cytarabine): deaths from any cause	Trial comparisons
Arm I (Daunorubicin, Cytarabine) vs Arm II (Uproleselan, Daunorubicin, Cytarabine): 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/NCT03701308

GET https://conductscience.org/api/trials/v1/NCT03701308/events?page=2

API reference For AI assistants