Trial · NCT06454409
Regorafenib in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT06454409, Phase 1, Suspended, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia. Trials, record NCT06454409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06454409
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia
- NCT number
- NCT06454409
- Status
- Suspended
- Phases
- Phase 1
- Enrollment
- 20 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Myelodysplastic Syndrome/Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Acute Myeloid Leukemia, Refractory Myelodysplastic Syndrome
- Interventions
- Azacitidine, Biospecimen Collection, Bone Marrow Aspiration, Regorafenib, Venetoclax
- First posted
- 2024-06-12
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicity (DLT) | Up to completion of cycle 1 (28 days) | DLT will be defined as any toxicities classified as at least possibly related to the study treatment, that occur during cycle 1 and will be used for dose escalation/de-escalation/expansion decisions. Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. |
| Primary | Incidence of adverse events (AEs) | Up to 30 days after last dose of study drug | AEs will be graded according to the NCI CTCAE v 5.0 and reported by type, frequency, severity, attribution, time course, and duration. |
| Secondary | Complete remission (CR) rate | Up to 1 year | Response will be determined using European LeukemiaNet criteria of Dohner et al. Response rates and Clopper-Pearson binomial confidence interval (CI) will be calculated for the CR (CR/ CR with incomplete hematologic recovery \[CRi\] / CR with partial hematologic recovery \[CRh\]) rate. CR rate will also be explored based on number/type of prior therapies. |
| Secondary | Overall response rate (ORR) | Up to 1 year | Response will be determined using European LeukemiaNet criteria of Dohner et al. Response rates and Clopper-Pearson binomial CI will be calculated for the ORR (CR/CRi/CRh/partial response \[PR\] / stable disease \[SD\]). ORR rate will also be explored based on number/type of prior therapies. |
| Secondary | Minimal residual disease (MRD) | Up to 1 year | MRD status will be determined by standard of care flow cytometry assay performed locally using a 0.01% blast threshold for positivity. MRD will be reported over the study period using both descriptive statistics and graphical methods. |
| Secondary | Time to CR | At first dose of study drug to up to 1 year | Time to CR will be defined as the time from first study dose to attainment of CR/ CRi/ CRh. Time to CR will be estimated using the product limit method of Kaplan-Meier. |
| Secondary | Time to first response | At first dose of study drug to first documented response up to 1 year | Time to first response will be defined as the time from first study dose to attainment of first documetned CR, CRi, CRh, morphologic leukemia-free state (MLFS) or PR. Time to first response will be estimated using the product limit method of Kaplan-Meier. |
| Secondary | Duration of response (DOR) | At first response to relapse or death up to 1 year | DOR will be defined as the time interval from the date of first documented response to the date of documented disease relapse or death whichever occurs first. DOR will be estimated using the product limit method of Kaplan-Meier. |
| Secondary | Overall survival (OS) | At first dose of study drug to death up to 1 year | OS will be defined as the time interval from the date of first study dose to the date of death from any cause. OS will be estimated using the product limit method of Kaplan-Meier. |
| Secondary | Progression-free survival (PFS) | At first dose of study drug to relapse, progression, or death up to 1 year | PFS will be defined as the time interval from the date of first study dose to the date of first documented disease relapse/progression or death from any cause, whichever occurs first. PFS will be estimated using the product limit method of Kaplan-Meier. |
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.
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 |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
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.
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/NCT06454409
GET https://conductscience.org/api/trials/v1/NCT06454409/registered