AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Description

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.

Conditions

Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndrome Acute Myeloid Leukemia

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Study Overview

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Study Details

Study overview

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.

A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Condition
Acute Myeloid Leukemia Refractory
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AB Science,

Norbert Vey, MD, PRINCIPAL_INVESTIGATOR, Institut Paoli Calmettes, Marseille, France

Nicholas Short, MD, PRINCIPAL_INVESTIGATOR, MD Anderson Cancer Center, Houston, Texas

Study Record Dates

2024-12