Trial · NCT05735184
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of dose limiting toxicities (DLTs) per dose level (Part 1a only) | During the first 28 days of ziftomenib in combination with SOC backbone treatment (1 cycle) | Assessed by the NCI-CTCAE v5.0 |
| Primary | Descriptive statistics of adverse events | From Cycle 1 Day 1 up to and including 28 days following the end of 36 months of treatment | Assessed by the NCI-CTCAE v5.0 |
| Primary | Complete remission (CR) rate | Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first | Assessed by the ELN 2022 criteria |
| Secondary | Composite Complete Remission (CRc) | Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first | Assessed by the ELN 2022 criteria |
| Secondary | Morphologic leukemia-free state (MLFS) rate | Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever comes first | Assessed by the ELN 2022 criteria |
| Secondary | Measurable residual disease (MRD) | Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first | Assessed by multiparameter flow cytometry (MFC) and/or molecular analysis (NGS, PCR) |
| Secondary | Median OS | From Cycle 1 Day 1 to date of death from any cause, assessed up to 36 months of treatment | To assess overall survival of ziftomenib |
| Secondary | Proportion of patients alive | From Cycle 1 Day 1 until death from any cause, assessed up to 1 year following start of treatment | To assess proportion of patients alive at 1 year following start of treatment with ziftomenib |
| Secondary | Median EFS | From Cycle 1 Day 1 to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months of treatment | To assess median event free survival |
| Secondary | EFS | From Cycle 1 Day 1 to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 1 year following start of treatment | To assess event free survival at 1 year |
| Secondary | Median DOR | From time of first remission to relapse or death, whichever occurs first, assessed up to 36 months from start of treatment | To assess median duration of remission |
| Secondary | Proportion of patients who undergo HSCT | From Cycle 1 Day 1 until date of HSCT, assessed up to 36 months of treatment | To assess proportion of patients who undergo hematopoietic stem cell transplant |
| Secondary | TI | From 28 days prior to Cycle 1 Day 1 up to and including 28 days following the end of 36 months of treatment | To assess rate of transfusion independence |
| Secondary | Cmax | Cycle 1; each cycle is 28 days | Maximum plasma concentration (Cmax) of ziftomenib and metabolites |
| Secondary | Tmax | Cycle 1; each cycle is 28 days | Time to maximum plasma concentration (Tmax) of ziftomenib and metabolites |
| Secondary | AUC0-last | Cycle 1; each cycle is 28 days | Area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last) of ziftomenib and metabolites |
| Secondary | AUCtau | Cycle 1; each cycle is 28 days | Area under the concentration-time curve over a dosing interval (AUCtau) of ziftomenib |
| Secondary | Accumulation ratio of ziftomenib and metabolites | Cycle 1; each cycle is 28 days | To assess accumulation ratio of ziftomenib and metabolites |
| Secondary | Cmax of venetoclax | Cycle 1; each cycle is 28 days | Maximum plasma concentration (Cmax) of venetoclax |
| Secondary | Tmax of venetoclax | Cycle 1; each cycle is 28 days | Time to maximum plasma concentration (Tmax) of venetoclax |
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/NCT05735184/registered