Trial · NCT04310592
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants who experience a Dose-limiting Toxicity (DLT) in MRD positive AML patients | Day +28 | The number of participants who experience a DLT will be measured. |
| Primary | Number of Participants who experience a Dose-limiting Toxicity (DLT) in Relapsed/Refractory AML patients | Day +28 | The number of participants who experience a DLT will be measured. |
| Primary | Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in MRD positive AML patients | up to 28 days | The maximum dose safely administered for the treatment of patients with AML. |
| Primary | Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in Relapsed/Refractory AML patients | up to 28 days | The maximum dose safely administered for the treatment of patients with AML. |
| Primary | Frequency and Severity of Adverse Events (AEs) | up to 12 months | Frequency and severity of Adverse Events will be evaluated. |
| Secondary | Number Participants who experience Minimal Residual Disease (MRD) Response | up to 12 months | The number of participants who convert from MRD positive to MRD negative in the MRD positive arm. |
| Secondary | Time to MRD Response | up to 12 months | The time it takes to convert from MRD positive to MRD negative in the MRD positive arm. |
| Secondary | Duration of MRD Response | up to 12 months | The measure of how long participants remain MRD negative in the MRD positive arm. |
| Secondary | Progression-free Survival (PFS) | up to 12 months | Date of first CYNK-001 infusion to date of disease progression in the MRD positive arm. |
| Secondary | Time to Progression (TTP) | up to 12 months | Date of first CYNK-001 infusion to date of disease progression in the MRD positive arm. |
| Secondary | Duration of Morphologic Complete Remission (CR) | up to 12 months | Duration from first Morphologic CR observation to time of disease progression in the MRD positive arm. |
| Secondary | Overall Survival (OS) | up to 12 months | Date of first CYNK-001 infusion to date of death. |
| Secondary | Overall Response Rate (ORR) | up to 12 months | Defined as achievement of Complete Remission (CR), Complete Remission with incomplete (CRi) hematologic recovery, or Morphologic leukemic-free state (MLFS) in the Relapsed/Refractory AML arm. |
| Secondary | Duration of Response (DoR) | up to 12 months | Duration of best response in the Relapsed/Refractory AML arm. |
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/NCT04310592/registered