Actively Recruiting
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Led by AB Science · Updated on 2025-10-02
78
Participants Needed
10
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of AB8939 in patients with relapsed or refractory acute myeloid leukemia (AML) and refractory myelodysplastic syndrome. This Phase 1/2, open-label study aims to determine dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for further studies, as well as to provide an early assessment of AB8939's effects. The study has two parts: a dose escalation phase and a dose expansion phase. In the first part, AB8939 is given intravenously daily to patients to assess safety, tolerability, and pharmacokinetics, with doses starting at 0.9 mg/m². The second part evaluates the recommended dose and schedule for a Phase 2 trial. AB8939 is studied both alone and in combination with venetoclax, which is given according to an escalating dose schedule. Participants will undergo regular assessments including bone marrow biopsies and clinical evaluations to monitor safety and response. Researchers will measure dose-limiting toxicities within 56 days as the primary outcome and assess objective response rates as a secondary outcome. The study includes ongoing monitoring and treatment over the study period, with participation lasting as defined by the treatment and follow-up schedule.
CONDITIONS
Brief Title
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with acute myeloid leukemia (AML) eligible for second or third line treatment
- Patients with refractory myelodysplastic syndrome in second or third line treatment with high risk based on IPSS-R score
- ECOG performance status 1 or lower for dose escalation; 2 or lower for expansion cohort
- Able to understand and sign informed consent before study procedures
- Willing and able to follow study procedures including bone marrow biopsies
You will not qualify if you...
- Patients eligible for standard of care treatment
- Patients eligible for hematopoietic stem cell transplantation at inclusion
- Diagnosis of acute promyelocytic leukemia (M3)
- Clinically active central nervous system leukemia
- Hematopoietic stem cell transplant within 100 days before first dose of AB8939
- Women who are breastfeeding, planning to breastfeed, or have a positive pregnancy test
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 56 days
Participants receive daily intravenous administration of AB8939, either alone or in combination with venetoclax, to assess safety, tolerability, and efficacy.
Daily visits for drug administration up to 56 days
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
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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