Tests AB8939 in adults with relapsed or refractory acute myeloid leukemia
Tests the safety of daily AB8939 infusions in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Key facts
- Where
- Alicante, Cáceres, Madrid, Sevilla, and Valencia, SpainSee the 8 sites
- Phase
- Phase 1/2
Where in Spain
- Hospital General Universitario Dr. BalmisAlicante, SpainNo longer taking part
- Hospital San Pedro De AlcántaraCáceres, SpainNo longer taking part
- Clinica Universidad de NavarraMadrid, SpainNo longer taking part
- Hospital MD Anderson Cancer Center MadridMadrid, SpainNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpainNo longer taking part
- Hospital Universitario Quirónsalud MadridMadrid, SpainNo longer taking part
- Hospital Universitario Virgen del RocíoSevilla, SpainNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AB Science
- Trial code
- NCT05211570EU 2024-516641-39-00
- Record updated
- 2 October 2025
- Original description
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.Read full original descriptionShow less
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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.
Inclusion: 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; 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: Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion; Patients with HSCT within 100 days prior to the first administration of AB8939; Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion; Patients with HSCT within 100 days prior to the first administration of AB8939; Patients eligible to a standard of care; Patients diagnosed with acute promyelocytic leukemia (M3); Patients with clinically active CNS leukemia; 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; Patients eligible to a standard of care; Patients diagnosed with acute promyelocytic leukemia (M3); Patients with clinically active CNS leukemia; 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.
DOSE ESCALATION STUDY.