Spots Global Cancer Trial Database for AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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Trial Identification
Brief Title: AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Official Title: A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Study ID: NCT05211570
Study Description
Brief 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.
Detailed Description: This is a Phase 1/2, open-label, multi-center, non-randomized, 2-part study in patients with refractory and relapsed AML and refractory myelodysplastic syndrome. Study AB18001 has a multi-stage design. The first part is a dose escalation study that aims to determine the safety, tolerability and pharmacokinetic profiles of consecutive daily intravenous administration of AB8939 in patients with refractory or relapsed AML or patients with refractory myelodysplastic syndrome, and to determine the recommended dose for the second-stage dose expansion study. This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy assessment of AB8939.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
MD Anderson Cancer Center, Houston, Texas, United States
Institut Paoli Calmettes, Marseille, , France
National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit, Athens, , Greece
General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante), Alicante, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Quirónsalud, Madrid, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Clínica Universidad de Navarra, Pamplona, , Spain
Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío), Sevilla, , Spain
Contact Details
Name: Norbert Vey, MD
Affiliation: Institut Paoli Calmettes, Marseille, France
Role: PRINCIPAL_INVESTIGATOR
Name: Nicholas Short, MD
Affiliation: MD Anderson Cancer Center, Houston, Texas
Role: PRINCIPAL_INVESTIGATOR
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