Trial · NCT06384261
A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy
NCT06384261, Phase 2, Active not recruiting, OncoVerity, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy. Trials, record NCT06384261. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06384261
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy
- NCT number
- NCT06384261
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 140 participants, estimated
- Lead sponsor
- OncoVerity, Inc.
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- Cusatuzumab, Venetoclax, Azacitidine
- First posted
- 2024-04-25
- Last updated
- 2026-05-11
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival | From date of randomization until the date of death from any cause, assessed up to 5 years | In all randomized participants |
| Secondary | Complete Remission rate (CR) | From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years | Proportion of participants achieving CR per the European LeukemiaNet (ELN) 2022 criteria |
| Secondary | Event-free survival (EFS) | From date of randomization to date of treatment failure, hematologic relapse from CR/CRh/CRi or death from any cause, assessed up to 5 years | Defined per ELN 2022 criteria |
| Secondary | Composite CR rate (CRc) | From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years | Sum of CR+CRh+CRi rate. CRh is defined as CR with partial hematologic recovery. CRi is defined as CR with incomplete hematologic recovery. Defined per ELN 2022 criteria. |
| Secondary | Rate of CRh and CRi | From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years | Defined per ELN 2022 criteria |
| Secondary | Duration of CR | From date of first CR to hematological relapse or death from any cause, assessed up to 5 years | Defined per ELN 2022 criteria |
| Secondary | Time to first CR | From date of randomization to first occurrence of CR, assessed up to 3 years | Defined per ELN 2022 criteria |
| Secondary | Rate of minimal residual disease (MRD) negativity in patients achieving CR, CRh, or CRi | From date of randomization to relapse or criteria for refractory disease are met, assessed up to 5 years | Defined per ELN 2022 criteria and guidelines for testing |
| Secondary | Proportion of participants proceeding to hematopoietic stem cell transplantation (HSCT) | From date of randomization to date of HSCT, assessed up to 5 years | |
| Secondary | OS in participants undergoing HSCT | From date of randomization to death from any cause, assessed up to 5 years |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT06384261
GET https://conductscience.org/api/trials/v1/NCT06384261/registered