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NCT06549790 · ClinicalTrials.gov registry record · Phase 1
Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia, sponsored by Nerviano Medical Sciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 124
- Enrollment target
- 7
- Study locations
NCT06549790: Recruiting Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia, sponsored by Nerviano Medical Sciences.
NCT06549790 is a Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by Nerviano Medical Sciences. The registered enrollment target is 124 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06549790, a Phase 1 study of Relapsed/Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Nerviano Medical Sciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 124 participants
- Enrollment target
- 7
- Study locations
Study Summary
The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.
Primary Outcome
Evaluation of AE frequency and severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 5.0), including dose limiting toxicities (DLTs), laboratory measurements, electrocardiogram (ECG) measurements, vital sign measurements
Conditions Studied
Interventions
- DRUG NMS-03597812
Study Locations (7)
California
- City of Hope - Duarte - Duarte
Colorado
- Rocky Mountain Cancer Centers - Aurora
Delaware
- Medical Oncology Hematology Consultants - Newark
Georgia
- Blood and Marrow Transplant Group of Georgia - Atlanta
Minnesota
- Mayo Clinic Cancer Center (MCCC) - Rochester - Rochester
Ohio
- Gabrail Cancer Research Center - Canton
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2024-10-16 |
| Est. Completion | 2030-05-15 |
| Phase | Phase 1 |
What NCT06549790 shows while recruiting
NCT06549790 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher).
The record links to 1 condition, with Relapsed/Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which NMS-03597812 is the first listed.
NCT06549790 lists 7 locations in 7 states (California, Colorado, Delaware).
Frequently Asked Questions
What is clinical trial NCT06549790 about?
NCT06549790 is a clinical study titled "Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia". The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with...
What is the current status of trial NCT06549790?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2024-10-16. Estimated completion is 2030-05-15.
What conditions does trial NCT06549790 study?
This clinical trial studies the following conditions: Relapsed/Refractory Acute Myeloid Leukemia.
What interventions are being tested in trial NCT06549790?
The interventions under investigation include: NMS-03597812 (DRUG).
Who is sponsoring clinical trial NCT06549790?
This trial is sponsored by Nerviano Medical Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06549790 being conducted?
This trial has 7 study locations across California, Colorado, Delaware, Georgia, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06549790's enrollment target sits among peer trials
124 472nd of 2000 higher than 1,526 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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