AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT ID: NCT05211570
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
78 participants
INTERVENTIONAL
2022-06-01
2026-12-31
Brief Summary
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Detailed Description
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Study AB18001 has a multi-stage design. The first part is a dose escalation study that aims to determine the safety, tolerability and pharmacokinetic profiles of consecutive daily intravenous administration of AB8939 in patients with refractory or relapsed AML or patients with refractory myelodysplastic syndrome, and to determine the recommended dose for the second-stage dose expansion study. This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy assessment of AB8939.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AB8939
AB8939 administered as a single agent
AB8939
Intravenous injection (from an initial dose of 0.9 mg/m²)
AB8939 plus Venetoclax
AB8939 administered in combination with venetoclax
AB8939
Intravenous injection (from an initial dose of 0.9 mg/m²)
Venetoclax
the recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.
Interventions
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AB8939
Intravenous injection (from an initial dose of 0.9 mg/m²)
Venetoclax
the recommended starting dose for AML indication is 100 mg. Dose escalating regimen as per SmPC.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
EXPANSION COHORT STUDY
* 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
18 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Norbert Vey, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli Calmettes, Marseille, France
Nicholas Short, MD
Role: PRINCIPAL_INVESTIGATOR
MD Anderson Cancer Center, Houston, Texas
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Institut Paoli Calmettes
Marseille, , France
National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit
Athens, , Greece
General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)
Alicante, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Quirónsalud
Madrid, , Spain
MD Anderson Cancer Center Madrid
Madrid, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío)
Seville, , Spain
Countries
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Central Contacts
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References
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Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. In Vivo Assessment of the Next Generation Microtubule-Destabilizing Agent AB8939 in Patient-derived Xenograft Models of Acute Myeloid Leukemia. Blood (2019) 134 (Supplement_1): 5142. doi.org/10.1182/blood-2019-127143
Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. AB8939, a Microtubule-Destabilizing Agent with Potential to Overcome Multidrug Resistance, is Active Across the Range (M0-M7) of Acute Myeloid Leukemia Subtypes. Blood (2019) 134 (Supplement_1): 5154. doi.org/10.1182/blood-2019-127021
Humbert M, Goubard A, Mansfield C, Hermine O, Dubreuil P, et al. Anticancer Activity of a Highly Potent Small Molecule Tubulin Polymerization Inhibitor, AB8939. Blood (2019) 134 (Supplement_1): 2075. doi.org/10.1182/blood-2019-122540
Other Identifiers
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2020-005122-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AB18001
Identifier Type: -
Identifier Source: org_study_id
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