Trial · NCT07451912
Venetoclax Plus Hypomethylating Agents and Subcutaneous Cytarabine for CEBPA-Mutated AML
NCT07451912, Phase 1, Phase 2, Recruiting, The First Affiliated Hospital of Soochow University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Venetoclax Plus Hypomethylating Agents and Subcutaneous Cytarabine for CEBPA-Mutated AML. Trials, record NCT07451912. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07451912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Venetoclax Plus Hypomethylating Agents and Subcutaneous Cytarabine for CEBPA-Mutated AML
- NCT number
- NCT07451912
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 29 participants, estimated
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Conditions
- Acute Myeloid Leukemia (AML), CEBPA Mutation, Unfit, New-diagnosis AML
- Interventions
- Venetoclax + Hypomethylating Agents + Low-Dose Cytarabine for CEBPA-Mutated AML (Unfit Patients)
- First posted
- 2026-03-05
- Last updated
- 2026-03-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse-Free Survival (RFS) | From date of achieving CR/CRi until first occurrence of disease relapse or death from any cause, assessed up to 48 months (2 years after the last patient has been enrolled into the study). | Defined as the time from the date of achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) to the first occurrence of disease relapse (reappearance of ≥5% blasts in the bone marrow, presence of blasts in the peripheral blood, or new extramedullary disease) or death from any cause, whichever comes first. For participants who remain in remission at the end of the follow-up period, RFS is censored at the date of the last confirmed remission assessment. |
| Secondary | Composite Remission Rate after 2 Induction Cycles | Proportion of participants who achieve CR or CRi after completing 2 cycles of induction therapy. (Each cycle is 28 days) | Proportion of participants who achieve CR or CRi after completing 2 cycles of induction therapy. (Each cycle is 28 days) CR: Defined by the following criteria simultaneously: bone marrow blasts \<5%, no blasts in the peripheral blood, absolute neutrophil count \>1.0×10⁹/L, platelet count \>100×10⁹/L, no extramedullary infiltration, and no relapse within 4 weeks. CRi: Meets all CR criteria except for incomplete hematologic recovery (absolute neutrophil count ≤1.0×10⁹/L or platelet count ≤100×10⁹/L). |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | 21 to 28 days after the end of every treatment | Proportion of participants with MRD \<1×10-⁴ detected by flow cytometry after treatment. |
| Secondary | Duration of Remission (DOR) | From date of achieving CR/CRi until first occurrence of disease relapse or death from any cause, assessed up to 60 months. | If no relapse or death occurs during follow-up, DOR is censored at the last follow-up date. |
| Secondary | Relapse Rate | Proportion of participants who experience disease relapse after achieving CR/CRi, assessed up to 48 months (2 years after the last patient has been enrolled into the study). | Proportion of participants who experience disease relapse after achieving CR/CRi during the study period. |
| Secondary | Overall Survival (OS) | From start of treatment until death from any cause, assessed up to 48 months (2 years after the last patient has been enrolled into the study). | Time from the start of treatment to death from any cause. For participants who remain alive at the end of the follow-up period, OS is censored at the date of the last survival confirmation. |
Source ClinicalTrials.gov
Outcomes0
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.
Data dates
The day each source was copied for this release.
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/NCT07451912
GET https://conductscience.org/api/trials/v1/NCT07451912/registered