Trial · NCT04214860

APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

NCT04214860, Phase 1, Completed, Aprea Therapeutics; results first posted 2025-02-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies. Trials, record NCT04214860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04214860

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Trial

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

Title: APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies
NCT number: NCT04214860
Status: Completed
Phases: Phase 1
Enrollment: 51 participants, actual
Lead sponsor: Aprea Therapeutics
Conditions: Myeloid Malignancy
Interventions: APR-246, Venetoclax, Azacitidine
First posted: 2020-01-02
Last updated: 2025-03-17
Results first posted: 2025-02-21

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies.	From baseline until event occures, i.e. through study completion, an average of 1 year	1\. Dose-limiting toxicities (DLTs), classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0).
Primary	To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies.	From baseline until event occures, i.e. through study completion, an average of 1 year	2\. Frequency of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs) related to APR-246 in combination with venetoclax and azacitidine during the trial.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies.	From baseline until event occures, i.e. through study completion, an average of 1 year		DLTs	NUMBER
PRIMARY	To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies.	From baseline until event occures, i.e. through study completion, an average of 1 year	Any Serious TEAEs	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies.	Cohort 1	0	DLTs
To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies.	Cohort 2	0	DLTs
To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies.	Cohort 1	5	Participants
To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies.	Cohort 2	32	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1	6
Overall Study	STARTED	Cohort 2	45
Overall Study	COMPLETED	Cohort 1	6
Overall Study	COMPLETED	Cohort 2	43
Overall Study	NOT COMPLETED	Cohort 1	0
Overall Study	NOT COMPLETED	Cohort 2	2

Source ClinicalTrials.gov

Adverse events232

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
other	Nasuea	Gastrointestinal disorders	Cohort 1	6	6
other	Nasuea	Gastrointestinal disorders	Cohort 2	27	43
other	Diarrhea	Gastrointestinal disorders	Cohort 1	3	6
other	Diarrhea	Gastrointestinal disorders	Cohort 2	24	43
other	Vomiting	Gastrointestinal disorders	Cohort 1	3	6
other	Vomiting	Gastrointestinal disorders	Cohort 2	20	43
other	Febrile Neutropenia	Blood and lymphatic system disorders	Cohort 1	4	6
other	Febrile Neutropenia	Blood and lymphatic system disorders	Cohort 2	19	43
other	Decreased Appetite	Gastrointestinal disorders	Cohort 1	2	6
other	Decreased Appetite	Gastrointestinal disorders	Cohort 2	18	43

1 to 10 of 232Source ClinicalTrials.gov

See all 232 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1	6	6
Total, all-cause mortality	Cohort 2	26	43
Total, other adverse events	Cohort 1	6	6
Total, other adverse events	Cohort 2	43	43
Total, serious adverse events	Cohort 1	5	6
Total, serious adverse events	Cohort 2	32	43

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36990622	DERIVED

Source PubMed

Grants0

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.

None in this release.

Trial comparisons3

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

Comparison	Source
Cohort 1 vs Cohort 2: To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies.	Trial comparisons
Cohort 1 vs Cohort 2: deaths from any cause	Trial comparisons
Cohort 1 vs Cohort 2: 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/NCT04214860

GET https://conductscience.org/api/trials/v1/NCT04214860/events?page=2

API reference For AI assistants