Trial · NCT04150887
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 | Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety | Up to 42 months | Frequency and severity of AEs, laboratory abnormalities, and physical exam findings will be reported. |
| Secondary | Serum Concentration of Cusatuzumab | Up to 23 months | Serum concentration of cusatuzumab will be assessed. |
| Secondary | Number of Participants with Anti-cusatuzumab Antibodies | Up to 23 months | Number of participants with anti-drug antibodies to cusatuzumab will be reported. |
| Secondary | Percentage of Participants with Complete Response (CR) | Up to 42 months | Percentage of participants with complete response based on European Leukemia Network (ELN) 2017 response criteria assessment will be reported. |
| Secondary | Percentage of Participants with Complete Remission with Partial Hematological Recovery (CRh) | Up to 42 months | Percentage of participants with CRh will be reported based on ELN 2017 response criteria assessment. |
| Secondary | Percentage of Participants with CR with Incomplete Recovery (CRi) | Up to 42 months | Percentage of participants with CRi will be reported based on ELN 2017 response criteria assessment. |
| Secondary | Percentage of Participants with CR plus CRh | Up to 42 months | Percentage of participants with CR plus CRh will be reported based on ELN 2017 response criteria assessment. |
| Secondary | Overall Response Rate (ORR) | Up to 42 months | ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria assessment. |
| Secondary | Percentage of Participants with CR without MRD | Up to 42 months | Percentage of participants with CR without minimal residual disease (MRD) will be reported and is defined as less than (\<) 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3). |
| Secondary | Percentage of Participants with Negative MRD who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS) | Up to 42 months | Percentage of participants with negative MRD who achieved CR, CRh, CRi, or MLFS will be reported and is defined as \< 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3). |
| Secondary | Cohort 2 and 3: Time to Response | Up to 42 months | Time to response is defined as time from first dose to achieving the first response of CR, CRh, or CRi. |
| Secondary | Cohort 2 and 3: Duration of Response | Up to 42 months | Duration of response is defined as time from achieving the first response of CR, CRh, or CRi to hematologic relapse or death of any cause. |
| Secondary | Cohort 2 and 3: Red Blood Cell (RBC) or Platelet Transfusion Independence | Up to 42 months | Transfusion independence (RBC or platelets) is defined as a period of greater than or equal to (\>=) 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug +30 days. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04150887/registered