Trial · NCT03092674
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) (Phase II) | Day of registration on study until death from any cause, assessed for up to 5 years | Time from date of randomization on study until death from any cause with observations censored on the day of last contact for patients not known to have died. |
| Primary | OS (Phase III) | Day of registration on study until death from any cause, assessed for up to 5 years | Time from date of randomization on study until death from any cause with observations censored on the day of last contact for patients not known to have died. |
| 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). | Only adverse events that are possibly, probably, or definitely related to study drugs are reported. CTCAE Version 5.0 was used for all AE reporting. |
| Other | Remission Rates | Up to 5 years | #participants(ps) w comp response(resp)(CR), comp remission w incomp bld ct recovery(CRp/CRi), morphol leukemia-free state(MLFS), erythroid\&neutrophil\&platelet resp(HI-E,HI-N,HI-P), HI-P, marrow comp resp(CRm), stable disease(SD), no resp(NR) CR:BM blasts\<5%; no circ blasts\&blasts w Auer rods(AR); no extramedullary disease(ED); ANC≥1x10\^9/L; plt ct≥100x10\^9/L CRp/CRi:CR criteria excl residual neutropenia\<1x10\^9/L or ITP\<100x10\^9/L MLFS:BM blasts\<5%; no blasts w AR, ED, hem recovery rqd HI-E:≥1.5g/dL↑Hb pretx;\&RBC trans-depen ps, achieve trans independ or relevant↓RBC trans rqd HI-N:ANC↑pretx≥100%,\&an absolute↑of\>500/mm3 pretx HI-P:Absolute↑≥30000/mm3 pretx for ps w plt ct\>20000/mm3 pretx. Ps w plt ct≤20000/mm3 pretx,↑≥100% pretx ct to plt ct\>20000/mm3. Plt trans-depend ps, plt trans independ rqd CRm:CR for BM exam≤5%myeloblasts\&marrow myeloblasts↓≥50%pretx SD:Not achieve≥PR, w no evidence prog NR:Not achieve CR,CRi,PR,MLFS,SD, excl ps w death in aplasia or due to indet cause |
| Other | OS | Day of registration on study until death from any cause, assessed for up to 5 years | Will be estimated using the Kaplan-Meier method or Cox regression models. Landmark analyses of different response categories will be evaluated based on dates at which 75% and 90% of patients have achieved a response (with other quantiles analyzed as needed). |
| Other | 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 | Time from the date of achievement of a remission (defined as patients achieving complete remission (CR), or CR with incomplete hematological recovery (CRi)) until the date of relapse or death from any cause; patients not known to have relapsed or died at last follow-up are censored on the date of last contact. |
| Other | 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 | Time from from the 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; patients not known to have any of these events are censored on the date of last contact. |
| Other | 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 | Cumulative incident endpoints and associations will be assessed using Cox regression models (for cause-specific hazards as appropriate). |
| Other | FLT3-ITD | Up to 5 years | The prognostic effect of FLT3-ITD (positive versus negative or non-evaluable) with respect to the outcome OS will be evaluated using Cox regression models. The predictive effect of FLT3-ITD (positive versus negative/non-evaluable) with respect to the outcome of OS and the treatments of azacitdine+midostaurin versus azacitidine will be evaluated using a Cox regression model with treatment arm and FLT3-ITD as covariates and including the interaction between the two covariates. |
| Other | Cytogenetic Abnormalities, Risk Categories, and Mutations in Bone Marrow | Up to 5 years | Univariate and multivariable regression models will be used to assess potential associations between outcomes (CR, OS, EFS, and RFS) and cytogenetic abnormalities and mutation status (including FLT3-ITD). Regression models including interaction terms with treatment arm will be fit. In addition to analyzing FLT3-ITD as categorical variable used in randomization stratification, we will analyze FLT3-TKD also and evaluate FLT3-ITD allelic ratio as a quantitative variable and as a binary variable using the threshold of 0.50. |
| Other | Potential Control Arm Drift | Up to 5 years | Only concurrently randomized patients will be evaluated in comparisons between arms. |
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.
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