ClinicalTrials.Veeva

Menu

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

AB Science logo

AB Science

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

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

Treatments

Drug: AB8939
Drug: Azacitidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05211570
AB18001
2020-005122-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

78 participants in 2 patient groups

AB8939
Experimental group
Description:
AB8939 administered as a single agent
Treatment:
Drug: AB8939
AB8939 plus azacitidine
Experimental group
Description:
AB8939 administered in combination with azacitidine
Treatment:
Drug: Azacitidine
Drug: AB8939

Trial contacts and locations

10

Loading...

Central trial contact

Clinical Study Coordinator

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems