Trial · NCT04614636
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 | Incidence of dose-limiting toxicities (DLTs) within each dose level cohort | Cycle 1, Up to Day 29 | |
| Primary | Nature of dose-limiting toxicities within each dose level cohort | Cycle 1, Up to Day 29 | |
| Secondary | Incidence, nature, and severity of adverse events (AEs) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r multiple myeloma | Up to 5 years | |
| Secondary | Objective response rate (ORR) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM | From baseline tumor assessment up to approximately 2 years after last dose of FT538 | Proportion of subjects who achieve a CR, CRMRD-, CRi, MLFS, or PR, as determined by the investigator according to 2017 ELN criteria for AML, and the proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG for MM response criteria |
| Secondary | Duration of response (DOR) of FT538 in combination with daratumumab or elotuzumab in r/r MM | Up to 15 years | Defined as the duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death due to progressive disease, as determined by the investigator according to standard IMWG response criteria |
| Secondary | Progression-free survival (PFS) of FT538 in combination with daratumumab or elotuzumab in r/r MM | Up to 15 years | Defined as the time from first dose of study treatment to disease progression or relapse, or to the day of death from any cause, as determined by the investigator according to standard IMWG response criteria |
| Secondary | Relapse-free survival (RFS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM | Up to 15 years | Defined as the time from initial CR (including CRMRD-, CR, and CRi) to hematologic relapse or death due to any cause, as determined by the investigator according to 2017 ELN criteria for AML, and defined as the duration from the start of sCR or CR until the time of relapse from sCR or CR, as determined by the investigator according to standard IMWG response criteria for MM |
| Secondary | Event-free survival (EFS) of FT538 as monotherapy in r/r AML | Up to 15 years | defined as the time from first dose of lympho-conditioning to the date of PD, or relapse from CR or CRi, or death from any cause, according to 2017 ELN criteria |
| Secondary | Overall survival (OS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM | Up to 15 years | defined as the time from first dose of lympho-conditioning to death from any cause |
| Secondary | Time-to-best response of FT538 as monotherapy in r/r AML | Up to 15 years | defined as the time from first dose of lympho-conditioning to best response |
| Secondary | Determination of the pharmacokinetics (PK) of FT538 cells in peripheral blood | Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29 | The PK of FT538 in peripheral blood will be reported as the relative percentage of product (FT538) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points |
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
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GET https://conductscience.org/api/trials/v1/NCT04614636/registered