Trial · NCT03092674
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) (Phase II) | Day of registration on study until death from any cause, assessed for up to 5 years | The analysis population includes the 76 participants who were eligible and evaluable (26 in the Azacitidine arm, 25 in the Azacitidine+Nivolumab arm, and 25 in the Azacitidine+Midostaurin arm). | months | MEDIAN |
| PRIMARY | OS (Phase III) | Day of registration on study until death from any cause, assessed for up to 5 years | Due to unexpected toxicities on the Azacitidine + Nivolumab arm during the first two cycles of therapy, the trial was closed early, before the phase II portions was completed and before reaching the phase III portion. | ||
| SECONDARY | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up until death or 5 years post randomization (registration to Step 2). | Participants who were eligible and received at least one dose of protocol treatment. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Remission Rates | Up to 5 years | The analysis population includes the 76 participants who were eligible and evaluable (26 in the Azacitidine arm, 25 in the Azacitidine+Nivolumab arm, and 25 in the Azacitidine+Midostaurin arm). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | OS | Day of registration on study until death from any cause, assessed for up to 5 years | |||
| OTHER_PRE_SPECIFIED | Relapse-free Survival (RFS) | Date of achievement of a remission until the date of relapse or death from any cause, assessed for up to 5 years | The analysis population includes the 17 participants who were eligible and evaluable and had complete response or complete remission with incomplete blood count recovery (CRp/CRi) (6 in the Azacitidine arm, 5 in the Azacitidine+Nivolumab arm, and 6 in the Azacitidine+Midostaurin arm). | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Event-free Survival (EFS) | Date of randomization to the first of: date of primary refractory disease; date of progressive disease; date off protocol therapy without CR or CRi; date of relapse from CR or CRi, or death from any cause, assessed for up to 5 years | The analysis population includes the 76 participants who were eligible and evaluable (26 in the Azacitidine arm, 25 in the Azacitidine+Nivolumab arm, and 25 in the Azacitidine+Midostaurin arm). | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Cumulative Incidence of Relapse Defined as Achieving CR or CRi | Date of achievement of a remission until the date of relapse or death, assessed for up to 5 years | |||
| OTHER_PRE_SPECIFIED | FLT3-ITD | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Cytogenetic Abnormalities, Risk Categories, and Mutations in Bone Marrow | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Potential Control Arm Drift | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03092674/outcomes