Actively Recruiting
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Led by AB Science · Updated on 2025-10-02
78
Participants Needed
10
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.
CONDITIONS
Official Title
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with documented diagnosis of acute myeloid leukemia (AML) based on the World Health Organization classification and eligible to second or third line of treatment
- Patients with documented diagnosis of refractory myelodysplastic syndrome in second or third line of treatment, with high risk prognosis based on IPSS-R scoring
- ECOG performance status 64 1 for dose escalation study; 64 2 for expansion cohort study
- Patients able to understand, sign, and date the written informed consent form prior to protocol procedures
- Patients willing and able to comply with study procedures, including bone marrow biopsies
You will not qualify if you...
- Patients eligible to standard of care
- Patients eligible to hematopoietic stem cell transplantation (HSCT) at time of inclusion
- Patients diagnosed with acute promyelocytic leukemia (M3)
- Patients with clinically active central nervous system (CNS) leukemia
- Patients with HSCT within 100 days prior to first administration of AB8939
- Women who are lactating, breastfeeding, or planning to breastfeed during the study
- Women with a positive pregnancy test
AI-Screening
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Trial Site Locations
Total: 10 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
2
Institut Paoli Calmettes
Marseille, France
Not Yet Recruiting
3
National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit
Athens, Greece
Actively Recruiting
4
General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)
Alicante, Spain
Actively Recruiting
5
Hospital San Pedro de Alcantara
Cáceres, Spain
Actively Recruiting
6
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
7
Hospital Universitario Quirónsalud
Madrid, Spain
Actively Recruiting
8
MD Anderson Cancer Center Madrid
Madrid, Spain
Actively Recruiting
9
Clínica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
10
Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)
Seville, Spain
Actively Recruiting
Research Team
C
Clinical Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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