NCT05211570RecruitingPhase 1/2
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 12 Jan 2022
- Start date
- Jun 2022
- Primary completion date
- Aug 2026
- Lead sponsor
- AB Science
- NCT number
- NCT05211570
- EudraCT number
- 2020-005122-28
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 78
- From Jun 2022 to the primary completion date, Aug 2026
- 10 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Criteria the registry did not label
- DOSE ESCALATION STUDY
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante) Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Recruiting |
| MD Anderson Cancer Center Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Quirónsalud Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío) Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.