Trial · NCT03512197
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Free Survival (EFS) | From date of Randomization up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) (Key Secondary) | Between randomization to date of death up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Hematological Recovery (CRi) But With Adequate Blood Count Recovery Rate. | At maximum 93 days from induction therapy start | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Minimal Residual Disease (MRD) Negative Status | from start of treatment up to end of post-consolidation (approximately 17 months) | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Minimal Residual Disease (MRD) Negative Status During Post-consolidation Phase | from start of post-consolidation to end of post-consolidation phase (up to 12 months) | Full analysis in post-consolidation phase comprised of participants who entered post-consolidation phase | Percentage of participants | NUMBER |
| SECONDARY | Time to Measurable Residual Disease (MRD) Negativity by Flow Cytometry | From date of Randomization up to approx. 17 months | Analysis set comprised all participants to whom study drug was assigned by randomization. | Days | MEDIAN |
| SECONDARY | Disease-free Survival (DFS) | From date of CR or CRi with adequate blood count recovery up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. DFW was derived only for participants who reached CR or CRi with adequate blood count recovery in induction (during first 93 days). | Months | MEDIAN |
| SECONDARY | Cumulative Incidence of Relapse (CIR) | From date of CR or CRi with adequate blood count recovery up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. CIR was only for participants who achieved CR or CRi with adequate blood count recovery. | Months | MEDIAN |
| SECONDARY | Cumulative Incidence of Death (CID) | From date of CR or CRi with adequate blood count recovery up to approx. 30 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. CID was only for participants who achieved CR or CRi with adequate blood count recovery. | Months | MEDIAN |
| SECONDARY | Time to CR or CRi With Adequate Blood Count Recovery | At maximum 93 days from induction therapy start | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Days | MEDIAN |
| SECONDARY | Time to Partial and Full Neutrophil Recovery | At maximum 93 days from induction therapy start | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Months | MEDIAN |
| SECONDARY | Time to Partial and Full Platelet Recovery | At maximum 93 days from induction therapy start | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Months | MEDIAN |
| SECONDARY | Plasma Concentrations for Midostaurin and Its Metabolites: CGP52421 and CGP62221 for Non-poor Metabolizers | from Induction (IND) phase 0hr (predose) to Post-consolidation phase (POSTCONS) 12hr | Pharmacokinetic analysis set-all (PAS-all) included all participants in the safety set who provided at least one evaluable PK concentration for Non-poor metabolizers. PK samples were not collected in all timepoints of all patients and reported for Non-poor metabolizers only. | hour (hr) | MEAN |
| SECONDARY | AUC0-t: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8 | 0 - 12 hrs | Pharmacokinetic analysis set-all (PAS-all) included all participants in the safety set who provided at least one evaluable PK concentration. | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | AUClast: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8 | 0 - 12 hrs | Pharmacokinetic analysis set-all (PAS-all) included all participants in the safety set who provided at least one evaluable PK concentration. | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8 | 0 - 12 hrs | Pharmacokinetic analysis set-all (PAS-all) included all participants in the safety set who provided at least one evaluable PK concentration. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Tmax: Pharmacokinetic (PK) Parameter for Midostaurin and Its Metabolites: CGP52421 and CGP62221 at Cycle 1, Day 8 | 0 - 12 hrs | Pharmacokinetic analysis set-all (PAS-all) included all participants in the safety set who provided at least one evaluable PK concentration. | hour (hr) | GEOMETRIC_MEAN |
| SECONDARY | Total Score for Each Time Point for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | From date of Randomization up to approx. 18 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Scores on a scale | MEAN |
| SECONDARY | Scores for Each Time Point for the EQ5D-5L (a Visual Analogue Scale (VAS)) | From date of Randomization up to approx. 18 months | Full analysis set comprised all participants to whom study drug was assigned by randomization. | Scores on a scale | MEAN |
| POST_HOC | All Collected Deaths | Start of study treatment up to 30 days post-treatment for approx. 1 year, prior to study treatment up to LPLV, approx. 18 months | Clinical Database Population: all enrolled participants | Participants | COUNT_OF_PARTICIPANTS |
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.
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GET https://conductscience.org/api/trials/v1/NCT03512197/outcomes