Status:
RECRUITING
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
AB Science
Conditions:
Acute Myeloid Leukemia Refractory
Acute Myeloid Leukemia, in Relapse
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
This is a Phase 1/2, open-label, multi-center, non-randomized, 2-part study in patients with refractory and relapsed AML and refractory myelodysplastic syndrome. Study AB18001 has a multi-stage desig...
Eligibility Criteria
Inclusion
- DOSE ESCALATION STUDY
- Key
- Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.
- Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.
- ECOG performance status ≤ 1
- Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies
- Key
Exclusion
- Patients eligible to a standard of care
- Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
- Patients diagnosed with acute promyelocytic leukemia (M3)
- Patients with clinically active CNS leukemia
- Patients with HSCT within 100 days prior to the first administration of AB8939
- Women who are lactating/breastfeeding or who plan to breastfeed while on study
- Women with a positive pregnancy test
- Other protocol-defined inclusion/exclusion criteria may apply
- EXPANSION COHORT STUDY
- Key Inclusion Criteria:
- Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.
- ECOG performance status ≤ 2
- Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies
- Key
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05211570
Start Date
June 1 2022
End Date
December 1 2026
Last Update
October 2 2025
Active Locations (10)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Institut Paoli Calmettes
Marseille, France
3
National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit
Athens, Greece
4
General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)
Alicante, Spain