Trial · NCT04241549
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 3 years | Number of participants with AEs and SAEs will be reported. |
| Primary | Part 1 and Part 2: Number of Participants with Dose-Limiting Toxicity (DLTs) | Up to 42 days | Number of participants with DLTs will be reported. |
| Primary | Part 1 and Part 2: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) | Up to 42 days | Severity of DLT as assessed by NCI-CTCAE in participants will be reported. |
| Secondary | Part 1 and Part 2: Percentage of Participants with Complete Response (CR) | Up to 9 months | Percentage of participants with complete response based on response criteria per investigator assessment in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) will be reported. |
| Secondary | Part 1: Objective Response Rate (ORR) | Up to 6 months | ORR is defined as percentage of participants with CR, CRh and CRi based on response criteria per investigator assessment in participants with AML. |
| Secondary | Part 2: Objective Response Rate (ORR) | Up to 9 months | ORR is defined as the percentage of participants with CR, partial response (PR) and marrow CR based on response criteria per investigator assessment in participants with MDS. |
| Secondary | Part 2: Percentage of Participants with Hematologic Improvement (HI) | Up to 9 months | Percentage of participants with hematologic improvement will be reported according to response criteria per investigator assessment in participants with MDS. |
| Secondary | Part 1 and Part 2: Time to Response | Up to 3 years | Time to response is defined as time from first dose to achieving the first response of CR, CRh, or CRi in participants with AML and CR, PR or marrow CR in participants with MDS.. |
| Secondary | Part 1 and Part 2: Duration of Response | Up to 3 years | Duration of response is defined as time from achieving the first response of CR, CRh, or CRi in participants with AML and CR, PR or marrow CR in participants with MDS to hematologic relapse or death of any cause. |
| Secondary | Part 1 and Part 2: Red Blood Cell (RBC) or Platelets Transfusion Independence | Up to 3 years | Transfusion independence (RBC or platelets) is defined as a period of at least 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug +30 days. |
| Secondary | Part 1 and Part 2: Overall Survival (OS) | Up to 3 years | OS is defined as the time from initial study intervention administration to death from any cause. |
| Secondary | Part 1 and Part 2: Maximum Serum Concentration (Cmax) of Cusatuzumab | Up to 3 years | Cmax is the maximum observed serum concentration. |
| Secondary | Part 1 and Part 2: Serum Trough Concentration (Ctrough) of Cusatuzumab | Up to 3 years | Ctrough is the serum concentration immediately prior to the next drug administration. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04241549/registered