AB8939 treatment for patients with relapsed or refractory acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of AB8939 in patients with relapsed or refractory acute myeloid leukemia (AML) and refractory myelodysplastic syndrome. It consists of a two-part design, starting with a dose escalation phase to identify the maximum tolerated dose and dose-limiting toxicities. Following this, a dose expansion phase will assess the treatment's efficacy and establish a schedule for a Phase 2 trial. The study is open-label and non-randomized, conducted across multiple centers.

Why it matters

Who can join: the full rules

DOSE ESCALATION 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.
* 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 Criteria:

* 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 Exclusion Criteria:

* 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

Where it's running

• National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit
  Athens, Greece Recruiting
• General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante)
  Alicante, Spain Recruiting
• Hospital San Pedro de Alcantara
  Cáceres, Spain Recruiting
• Hospital Universitario 12 de Octubre
  Madrid, Spain Recruiting
• Hospital Universitario Quirónsalud
  Madrid, Spain Recruiting
• MD Anderson Cancer Center Madrid
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Norbert Vey, MD — Institut Paoli Calmettes, Marseille, France
• Study coordinator: Clinical Study Coordinator
• Email: clinical@ab-science.com
• Phone: +33(0)147200014

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.