Trial · NCT04023526
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 | Percentage of Participants With Complete Remission (CR) | Up to 3 years and 5 months | Complete remission based on European Leukemia Network (ELN) 2017 response criteria. Defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L |
| Secondary | Percentage of Participants With CR With Partial Hematological Recovery (CRh) | Up to 3 years and 5 months | CRh defined as meeting all criteria for CR except ANC \>0.5x10\^9/L and platelet count \>50x10\^9/L |
| Secondary | Percentage of Participants With CR Plus CRh | Up to 3 years and 5 months | CR plus CRh based on ELN 2017 response criteria. CR defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L CRh defined as meeting all criteria for CR except ANC \>0.5x10\^9/L and platelet count \>50x10\^9/L |
| Secondary | Percentage of Participants With CR With Incomplete Recovery (CRi) | Up to 3 years and 5 months | CRi based on ELN 2017 response criteria. Defined as meeting all CR criteria except for residual neutropenia (ANC \<1.0x10\^9/L) or thrombocytopenia (platelets \<100x10\^9/L) |
| Secondary | Overall Response Rate (ORR) | Up to 3 years and 5 months | ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria. |
| Secondary | Percentage of Participants With CR Without MRD | Up to 3 years and 5 months | CR without minimal residual disease (MRD) defined as less than 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3 by flow cytometry). |
| Secondary | Percentage of Participants With Negative MRD Who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS) | Up to 3 years and 5 months | Percentage of participants with negative MRD who achieved CR, CRh, CRi, or MLFS will be reported and is defined as less than (\<) 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3). |
| Secondary | Time to First Response | Up to 3 years and 5 months | Defined as time from randomization to achieving the first response of CR, CRh, or CRi. |
| Secondary | Duration of First Response | Up to 3 years and 5 months | Defined as time from achieving the first response of CR, CRh, or CRi to disease relapse or death from any cause. |
| Secondary | Red Blood Cell (RBC) and/or Platelets Transfusion Independence | Up to 3 years and 5 months | Defined as a period of at least 56 consecutive days with no transfusion of RBC and/or platelets between first dose of study drug and the last dose of study drug +30 days. |
| Secondary | Cusatuzumab Minimum Serum Concentration (Cmin) | Cycle 1 Day 3 | Cmin is the minimum cusatuzumab serum concentration observed at Cycle 1 Day 3 |
| Secondary | Maximum Serum Concentration (Cmax) of Cusatuzumab | Cycle 1 Day 3 | Cmax is the maximum cusatuzumab serum concentration observed at Cycle 1 Day 3. |
| Secondary | Number of Participants With Anti-cusatuzumab Antibodies | Up to 3 years and 5 months | Number of participants exhibiting anti-drug antibodies for cusatuzumab. |
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.
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