Trial · NCT02399917

Lirilumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia

NCT02399917, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2019-09-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lirilumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia. Trials, record NCT02399917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02399917

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Trial

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

Title: Lirilumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
NCT number: NCT02399917
Status: Terminated
Phases: Phase 2
Enrollment: 36 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Acute Biphenotypic Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions: Azacitidine, Lirilumab
First posted: 2015-03-26
Last updated: 2019-09-24
Results first posted: 2019-09-24

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose of Iirilumab in Combination With 5-azacitidine	Up to 28 days	To identify the dose at which \<2/6 participants experience Dose Limiting Toxicities (DLT). The dose level at which 0-1/6 participants experience a DLT in the first 28 days of treatment will be the maximum tolerated dose (MTD) and would be used to treat an additional 34 participants in the phase II potion of the study. (Part A, Lead-In Phase)
Primary	Participants With an Objective Response	Up to 3 months	Objective Response Rate (ORR) will be monitored using the Bayesian approach of Thall, Simon, Estey and the extension by Thall and Sung. Overall response rate (ORR), defined as complete remission (CR) + CR with incomplete platelet recovery (CRp) + CR with incomplete count recovery (CRi) + partial response (PR) + marrow clearance of blasts + hematological improvement within 3 months of treatment initiation among adult patients with refractory/relapsed Acute Myelogenous Leukemia (AML) (Phase II)
Secondary	Duration of Response	Up to 2.5 years	The date of Objective Response to the date of loss of response or last follow-up.
Secondary	Overall Survival	Up to 2 years	Overall Survival (OS) is defined: Time of presentation to date of death or censored at last follow-up date.
Secondary	Disease Free Survival	Up to 2.5 years	Disease Free Survival (DFS) is defined: Time from date of treatment start until the date of first objective documentation of disease-relapse

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	Maximum Tolerated Dose of Iirilumab in Combination With 5-azacitidine	Up to 28 days		mg/kg	NUMBER
PRIMARY	Participants With an Objective Response	Up to 3 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Response	Up to 2.5 years	The outcome for the secondary response, duration of response was only done on the Phase II portion of this study.	Months	MEDIAN
SECONDARY	Overall Survival	Up to 2 years	The outcome for the secondary response, overall response was only done on the Phase II portion of this study.	Months	MEDIAN
SECONDARY	Disease Free Survival	Up to 2.5 years	The outcome for the secondary response, disease free survival was only done on the Phase II portion of this study.	Months	MEDIAN

Source ClinicalTrials.gov

Results by group7

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

Outcome	Group	Value	Spread	Units
Maximum Tolerated Dose of Iirilumab in Combination With 5-azacitidine	All Phase 1 Participants	3.0		mg/kg
Participants With an Objective Response	Phase 1b Lead-in Cohort 1	2		Participants
Participants With an Objective Response	Phase 1b Lead-in Cohort 2	1		Participants
Participants With an Objective Response	Phase 2	2		Participants
Duration of Response	Phase 2	7.7	Full Range 2.0 to 17.0	Months
Overall Survival	Phase 2	3.5	Full Range 0.4 to 22.2	Months
Disease Free Survival	Phase 2	7.7	Full Range 2.0 to 17.0	Months

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase 1b Lead-in Cohort 1	6
Overall Study	STARTED	Phase 1b Lead-in Cohort 2	6
Overall Study	STARTED	Phase 2	24
Overall Study	COMPLETED	Phase 1b Lead-in Cohort 1	6
Overall Study	COMPLETED	Phase 1b Lead-in Cohort 2	6
Overall Study	COMPLETED	Phase 2	24
Overall Study	NOT COMPLETED	Phase 1b Lead-in Cohort 1	0
Overall Study	NOT COMPLETED	Phase 1b Lead-in Cohort 2	0
Overall Study	NOT COMPLETED	Phase 2	0

Source ClinicalTrials.gov

Adverse events219

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	Abdominal Distension	Gastrointestinal disorders	Phase 1b Lead-in Cohort 1	2	6	2
other	Abdominal Distension	Gastrointestinal disorders	Phase 1b Lead-in Cohort 2	0	6	0
other	Abdominal Distension	Gastrointestinal disorders	Phase 2	1	24	1
other	Acute Kidney Injury	Renal and urinary disorders	Phase 1b Lead-in Cohort 1	0	6	0
other	Acute Kidney Injury	Renal and urinary disorders	Phase 1b Lead-in Cohort 2	3	6	3
other	Acute Kidney Injury	Renal and urinary disorders	Phase 2	0	24	0
other	Elevated Alanine Aminotransferase increased	Investigations	Phase 1b Lead-in Cohort 1	0	6	0
other	Elevated Alanine Aminotransferase increased	Investigations	Phase 1b Lead-in Cohort 2	1	6	1
other	Elevated Alanine Aminotransferase increased	Investigations	Phase 2	2	24	2
other	Anorexia	Metabolism and nutrition disorders	Phase 1b Lead-in Cohort 1	0	6	0

1 to 10 of 219Source ClinicalTrials.gov

See all 219 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1b Lead-in Cohort 1	4	6
Total, all-cause mortality	Phase 1b Lead-in Cohort 2	2	6
Total, all-cause mortality	Phase 2	9	24
Total, other adverse events	Phase 1b Lead-in Cohort 1	6	6
Total, other adverse events	Phase 1b Lead-in Cohort 2	6	6
Total, other adverse events	Phase 2	22	24
Total, serious adverse events	Phase 1b Lead-in Cohort 1	6	6
Total, serious adverse events	Phase 1b Lead-in Cohort 2	6	6
Total, serious adverse events	Phase 2	20	24

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
P30CA016672	The University of Texas MD Anderson Cancer Center Support Grant (CCSG)	KOONG, ALBERT	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1985 to 2026

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT02399917

GET https://conductscience.org/api/trials/v1/NCT02399917/events?page=2

API reference For AI assistants