Trial · NCT03030612
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants with Dose Limiting Toxicity (DLT) | Up to 3.6 years | DLTs will be defined as any of the following drug-related events: Any grade 3 or higher drug related non-hematological toxicity or; Grade 3 or higher IRRs or; inability to administer the next dose due to a drug-related adverse event or a delay of the administration of the next dose due to toxicities for more than 14 days despite adequate medication or; drug-related grade 4 febrile neutropenia or; drug-related grade 4 anemia which cannot be adequately treated. |
| Primary | Phase 2: Overall Response Rate (ORR) | Up to 3.6 years | ORR is defined as the sum of Complete remission (CR), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR) at the ARGX-110 RP2D level that was established in Phase 1 according to established response criteria for Acute myeloid leukemia (AML). |
| Secondary | Phase 1 and Phase 2: Number of Participants with Adverse Events | Up to 3.6 years | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of ARGX-110 | Up to 3.6 years | Cmax is the maximum observed concentration. |
| Secondary | Phase 1 and Phase 2: Trough Concentration (Ctrough) of ARGX-110 | Up to 3.6 years | Ctrough is defined as the observed serum concentration before dosing or at the end of the dosing interval. |
| Secondary | Phase 1 and Phase 2: Area Under the Serum Concentration-Time Curve from Time Zero to Infinite (AUC[0-infinity]) of ARGX-110 | Up to 3.6 years | AUC(0-infinity) is defined as area under the serum analyte concentration-time curve from time 0 to infinite time of ARGX-110. |
| Secondary | Phase 1 and Phase 2: Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCtau) | Up to 3.6 years | AUCtau is the area under the serum concentration-time curve during the dosing interval. |
| Secondary | Phase 1 and Phase 2: Apparent Volume of Distribution (Vd/F) of ARGX-110 | Up to 3.6 years | Vd/F is defined as Dose/\[Lambda (z)\*AUC (0-infinity)\]. |
| Secondary | Phase 1 and Phase 2: Total Systemic Clearance (CL) of ARGX-110 | Up to 3.6 years | CL is the total systemic clearance of drug after intravenous (IV) administration. |
| Secondary | Phase 1 and Phase 2: Elimination Half-Life (t1/2) of ARGX-110 | Up to 3.6 years | t1/2 is defined as the time measured for the serum concentration to decrease by 1 half of its original concentration. |
| Secondary | Phase 1 and Phase 2: Number of Participants with Minimal Residual Disease (MRD) to ARGX-110 | Up to 3.6 years | Minimal residual disease assessments will be performed on bone marrow aspirates and/or whole blood by flow cytometry. |
| Secondary | Phase 1 and Phase 2: Number of Participants with Anti-drug Antibodies (ADA) to ARGX-110 | Up to 3.6 years | Venous blood samples and bone marrow aspirate will be used to evaluate presence of anti-drug antibodies to ARGX-110. Participants with titer of confirmed positive samples for ARGX-110 antibodies will be reported. |
| Secondary | Phase 1 and Phase 2: Number of Participants with Complete Remission (CR) | Up to 3.6 years | Complete remission is defined as number of participants who have bone marrow blasts less than (\<) 5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>) 1.0 \* 10\^9 per liter (L) (1000 per microliter \[µL\]); platelet count \> 100 \* 10\^9/L (100.000/mc); independence of red cell transfusions. |
| Secondary | Phase 1 and Phase 2: Number of Participants with CR with Incomplete Recovery (CRi) | Up to 3.6 years | CRi is defined as number of participants who have all CR criteria except for residual neutropenia (\< 1.0 \* 10\^9/L \[1000/mc\]) or thrombocytopenia (\< 100 \* 10\^9/L \[100.000/mc\]). |
| Secondary | Phase 1 and Phase 2: Number of Participants with Morphologic Leukemia-free State (MLFS) | Up to 3.6 years | MLFS is defined as number of participants who have bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. |
| Secondary | Phase 1 and Phase 2: Number of Participants with Partial remission (PR) | Up to 3.6 years | PR is defined as number of participants who have all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. |
| Secondary | Phase 1 and Phase 2: Time to Response | Up to 3.6 years | Time to response is defined as response measured from the time from first dose of study drug to date of response (CR, CRi, MLFS, PR). |
| Secondary | Phase 1 and Phase 2: Duration of Response | Up to 3.6 years | Duration of response is defined as the date of achievement of a response (CR, CRi, MLFS, PR) until the date of relapse. |
| Secondary | Phase 1 and Phase 2: Relapse-Free Survival (RFS) | Up to 3.6 years | RFS is defined as disease relapse or participant death from any cause; measured from the date of achievement of a remission (CR, CRi) until the date of relapse or death from any cause. |
| Secondary | Phase 1 and Phase 2: Overall Survival (OS) | Up to 3.6 years | OS is defined as death from any cause; measured from the date of first dose to the date of death from any cause. |
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/NCT03030612/registered