Trial · NCT04160052
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of the combination regimen of venetoclax and azacitidine (Phase I) | Up to 8 weeks | The MTD is the highest dose level in which \< 2 patients of 6 develop first cycle dose-limiting toxicity. |
| Primary | Incidence of adverse events (Phase I) | Up to 5 years | Safety data will be summarized by category, severity, and frequency. |
| Secondary | Overall response rate (Phase 2) | Up to 5 years | Will be defined as the proportion of patients who had complete remission (CR), partial remission (PR), marrow complete remission, or hematologic improvement lasting at least 4 weeks. Will estimate the overall response rate for the combination treatment, along with the 95% confidence interval. |
| Secondary | Rate of CR | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of marrow/morphologic CR | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of hematologic improvement | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of red blood cell transfusion independence | Up to 5 years | |
| Secondary | Rate of platelet transfusion independence | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of cytogenetic response | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Rate of bone marrow blast response | Up to 5 years | The association between response and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate. |
| Secondary | Time to transformation to acute myeloid leukemia | Up to 5 years | Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests. |
| Secondary | Duration of response | From the date of initial response (PR or better) to the date of first documented disease progression/relapse or death, whichever occurs first, assessed up to 5 years | Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests. |
| Secondary | Overall survival | From treatment start till death or last follow-up, assessed up to 5 years | Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests. |
| Secondary | Progression-free survival | From treatment to progression or last follow-up, assessed up to 5 years | Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests. |
| Secondary | Time to next myelodysplastic syndrome treatment | Up to 5 years | Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests. |
| Secondary | Event-free survival | From the date of treatment initiation to the date of documented treatment failure, relapses from CR, or death from any cause, whichever occurs first, assessed up to 5 years | Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests. |
| Other | Effects of therapy on myelodysplastic syndrome | Up to 5 years | |
| Other | Biological markers of response | Up to 5 years |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT04160052/registered