AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

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 expansion study.

Eligibility

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

Conditions4

Locations1 site

Browse More Trials