Trial · NCT03030612
A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
NCT03030612, Phase 1, Phase 2, Completed, OncoVerity, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS). Trials, record NCT03030612. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03030612
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
- NCT number
- NCT03030612
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- OncoVerity, Inc.
- Conditions
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
- Interventions
- ARGX-110, AZA
- First posted
- 2017-01-25
- Last updated
- 2023-08-09
- Other registries' IDs
- eudract:2016-002151-17
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32601337 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03030612
GET https://conductscience.org/api/trials/v1/NCT03030612/registered?page=2