RECRUITING

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

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Conditions

Acute Myeloid Leukemia RefractoryAcute Myeloid Leukemia, in RelapseMyelodysplastic Syndrome Acute Myeloid Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-06-01
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05211570

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * ECOG performance status ≤ 1
  4. * Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
  5. * Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies
  1. * Patients eligible to a standard of care
  2. * Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
  3. * Patients diagnosed with acute promyelocytic leukemia (M3)
  4. * Patients with clinically active CNS leukemia
  5. * Patients with HSCT within 100 days prior to the first administration of AB8939
  6. * Women who are lactating/breastfeeding or who plan to breastfeed while on study
  7. * Women with a positive pregnancy test

Contacts and Locations

Study Contact

Clinical Study Coordinator
CONTACT
+33(0)147200014
clinical@ab-science.com

Principal Investigator

Norbert Vey, MD
PRINCIPAL_INVESTIGATOR
Institut Paoli Calmettes, Marseille, France
Nicholas Short, MD
PRINCIPAL_INVESTIGATOR
MD Anderson Cancer Center, Houston, Texas

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-06-01
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

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