AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Launched by AB SCIENCE · Jan 14, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called AB8939 for patients with acute myeloid leukemia (AML) who have either not responded to previous treatments or whose cancer has come back. The main goal of the trial is to find out if AB8939 is safe and to determine the best dosage for future studies. To participate, patients should have a confirmed diagnosis of AML and be eligible for second or third line treatments. They should also have a good ability to take care of themselves, meaning they can perform daily activities with minimal assistance.

Participants in this trial can expect to undergo some procedures, including bone marrow biopsies, to help monitor their condition and the effects of the treatment. The study is currently recruiting patients aged 65 and older, and it welcomes individuals of all genders. It’s important to note that not everyone will be eligible; for example, those who can receive standard treatments or have had a stem cell transplant recently will not qualify. This trial provides an opportunity for patients seeking new treatment options for their AML.

Gender

ALL

Eligibility criteria

• • 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