ACTIVE_NOT_RECRUITING

Study of AZD9829 in CD123+ Hematological Malignancies

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Conditions

Hematological MalignanciesAZD9829Anti-cancer agentsDose escalation

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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

This is a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in participants with CD123 positive hematological malignancies.

Official Title

A Modular Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD9829 as Monotherapy or in Combination in Patients With CD123-Positive Hematological Malignancies

Quick Facts

Study Start:2024-01-31
Study Completion:2026-03-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06179511

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. * ≥18 years of age;
  2. * CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
  3. * R/R AML (except APL);
  4. * R/R HR-MDS with ≥5% bone marrow blast at time of inclusion;
  5. * Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
  6. * ECOG performance status of ≤ 2.
  1. * Active CNS leukemia;
  2. * Previous treatment with any CD123 targeting therapy;
  3. * Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy;
  4. * Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829;
  5. * History of other malignancy(with certain exceptions);
  6. * Active and uncontrolled infections;
  7. * Unresolved AEs ≥2 Grade, from prior therapies.

Contacts and Locations

Study Locations (Sites)

Research Site
Duarte, California, 91010
United States
Research Site
St Louis, Missouri, 63110
United States
Research Site
New York, New York, 10021
United States
Research Site
Chapel Hill, North Carolina, 27514
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

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 Date2024-01-31
Study Completion Date2026-03-23

Study Record Updates

Study Start Date2024-01-31
Study Completion Date2026-03-23

Terms related to this study

Keywords Provided by Researchers

  • AZD9829
  • Anti-cancer agents
  • Dose escalation

Additional Relevant MeSH Terms

  • Hematological Malignancies