Actively Recruiting
Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
Led by Nerviano Medical Sciences · Updated on 2025-10-31
124
Participants Needed
7
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of refractory or relapsed AML according to 2022 ELN recommendations
- Adults aged 18 years or older
- ECOG performance status of 0, 1, or 2
- For Phase Ia: patients who have exhausted standard therapy, including prior intensive chemotherapy or hypomethylating agent/venetoclax therapy
- For Phase Ib Cohort A: TP53 mutated patients with exhausted standard therapy as defined
- For Phase Ib Cohort B: TP53 wild-type patients with exhausted standard therapy as defined
- Interval from prior antitumor treatment of at least 2 weeks or 5 half-lives unless otherwise agreed
- All acute toxic effects from prior therapies resolved to Grade 1 or less (excluding hair loss)
- Adequate organ function
- Use of highly effective contraception or true abstinence during and after treatment as specified
- Ability to swallow capsules intact
- Willingness and ability to comply with study visits, treatment plan, tests, and procedures
- Signed informed consent form
You will not qualify if you...
- Currently enrolled in another interventional clinical trial (except survival follow-up)
- White blood cell count greater than 20 x10^3/microliter unless reduced before treatment
- Diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia
- Active second malignancy except some treated skin or cervical cancers
- Known leukemia involvement of the central nervous system
- Hematopoietic stem cell transplant within 3 months or related severe toxicities
- Active graft versus host disease requiring immunosuppressive treatment
- QTcF interval 470 milliseconds or greater or risk factors for certain heart arrhythmias
- Pregnancy or breastfeeding
- Known active gastrointestinal diseases affecting drug absorption
- Use of certain antacids or medications affecting drug metabolism that cannot be changed
- Major surgery or radiotherapy within 4 weeks before treatment
- History of severe pancreatitis within 6 months before treatment
- Other protocol-defined criteria may apply
AI-Screening
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Trial Site Locations
Total: 7 locations
1
City of Hope - Duarte
Duarte, California, United States, 91010
Actively Recruiting
2
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
Actively Recruiting
3
Medical Oncology Hematology Consultants
Newark, Delaware, United States, 19713
Actively Recruiting
4
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
Actively Recruiting
5
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, United States, 55905
Withdrawn
6
Gabrail Cancer Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
7
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Alberto Ocana
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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