A Phase III Study Comparing Mesutoclax + Azacitidine Versus Venetoclax + Azacitidine in Untreated Acute Myeloid Leukemia (AML) Patients
NCT07925190, Phase 3, Not yet recruiting, Beijing InnoCare Pharma Tech Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase III Study Comparing Mesutoclax + Azacitidine Versus Venetoclax + Azacitidine in Untreated Acute Myeloid Leukemia (AML) Patients | ClinicalTrials.gov |
| NCT number | NCT07925190 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 318 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing InnoCare Pharma Tech Co., Ltd. | ClinicalTrials.gov |
| Conditions | Acute Myeloblastic Leukaemia | ClinicalTrials.gov |
| Interventions | Mesutoclax (ICP-248), Azacitidine (AZA), Venetoclax | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | overall survival (OS) | through the study completion, approximately up to 4 years | ClinicalTrials.gov | |
| Secondary | Response rates | within 3 cycles (each cycle is 28 days) and during study treatment, approximately up to 3 years | Rate of complete remission with negative measurable residual disease (CRMRD-), complete remission (CR) rate, and composite complete remission (CRc) rate (CRc includes CR, CR with incomplete hematologic recovery \[CRi\] , and/or CR with partial hematological recovery(CRh)) | ClinicalTrials.gov |
| Secondary | Event free survival (EFS) | approximately up to 3 years | ClinicalTrials.gov | |
| Secondary | Duration of CR and CRc | during study treatment period, approximately up to 3 years | Duration of CR and duration of CRc | ClinicalTrials.gov |
| Secondary | EFS with molecular MRD relapse | approximately up to 3 years | Mesured from the date of randomization to date of treatment failure, hematological relapse, MRD relapse, or death from any cause, whichever comes first | ClinicalTrials.gov |
| Secondary | Transfusion independence rate | approximately up to 3 years | Transfusion independence rate | ClinicalTrials.gov |
| Secondary | Adverse event profile per CTCAE v5.0 | from first dose to 28 days post last dose, approximately up to 3 years | Incidence, category, severity, and other characteristics of adverse events (AEs), assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | ClinicalTrials.gov |
| Secondary | Numbers of Treatment cycle | during study treatment period, approximately up to 3 years | ClinicalTrials.gov | |
| Secondary | Treatment cycle duration | during study treatment period, approximately up to 3 years | ClinicalTrials.gov | |
| Secondary | Days of treatment per cycle | during study treatment period, approximately up to 3 years | ClinicalTrials.gov | |
| Secondary | Patient Reported Outcomes (PRO) by European Organization for Research and Treatment of Cancer -Quality of Life Questionnaire (EORTC-QLQ-C30) | from first dose to 28 days post last dose, approximately up to 3 years | PROs assessed by EORTC-QLQ-C30 , changes in rating compared to baseline. | ClinicalTrials.gov |
| Secondary | PRO by EuroQol 5-Dimension 5-Level (EQ-5D-5L) | from first dose to 28 days post last dose, approximately up to 3 years | PROs assessed by EQ-5D-5L, changes in rating compared to baseline. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)