Trial · NCT06384261
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival | From date of randomization until the date of death from any cause, assessed up to 5 years | In all randomized participants |
| Secondary | Complete Remission rate (CR) | From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years | Proportion of participants achieving CR per the European LeukemiaNet (ELN) 2022 criteria |
| Secondary | Event-free survival (EFS) | From date of randomization to date of treatment failure, hematologic relapse from CR/CRh/CRi or death from any cause, assessed up to 5 years | Defined per ELN 2022 criteria |
| Secondary | Composite CR rate (CRc) | From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years | Sum of CR+CRh+CRi rate. CRh is defined as CR with partial hematologic recovery. CRi is defined as CR with incomplete hematologic recovery. Defined per ELN 2022 criteria. |
| Secondary | Rate of CRh and CRi | From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years | Defined per ELN 2022 criteria |
| Secondary | Duration of CR | From date of first CR to hematological relapse or death from any cause, assessed up to 5 years | Defined per ELN 2022 criteria |
| Secondary | Time to first CR | From date of randomization to first occurrence of CR, assessed up to 3 years | Defined per ELN 2022 criteria |
| Secondary | Rate of minimal residual disease (MRD) negativity in patients achieving CR, CRh, or CRi | From date of randomization to relapse or criteria for refractory disease are met, assessed up to 5 years | Defined per ELN 2022 criteria and guidelines for testing |
| Secondary | Proportion of participants proceeding to hematopoietic stem cell transplantation (HSCT) | From date of randomization to date of HSCT, assessed up to 5 years | |
| Secondary | OS in participants undergoing HSCT | From date of randomization to death from any cause, assessed up to 5 years | |
| Secondary | Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation | Signing of informed consent to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy | Per CTCAE criteria |
| Secondary | Incidence of dose modifications due to AEs | Randomization to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy | Includes interruptions and/or delays |
| Secondary | Number of participants with abnormal laboratory test results | Signing of informed consent to 30 days after the last dose of study treatment or until start of subsequent anti-AML therapy | Findings will be summarized |
| Secondary | Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) | From date of randomization to end of treatment, assessed up to 5 years | |
| Secondary | Overall survival in subgroups of participants according to specified AML risk stratification models | From date of randomization to death from any cause, assessed up to 5 years | |
| Secondary | Complete Remission rate | From date of randomization to relapse or criteria for refractory disease are met, assessed up to 3 years | In subgroups of participants according to specified AML risk stratification models. CR defined per ELN 2022 criteria. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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