NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Study of AZD9829 in CD123+ Hematological Malignancies

CompletedPhase 1, Phase 2

Sponsor: AstraZeneca

Conditions: Hematological Malignancies

Interventions: AZD9829, AZD9829

Countries: United States, Australia, China, Germany, Italy, Japan, South Korea, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* ≥18 years of age;
* CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;

  * R/R AML (except APL);
  * R/R HR-MDS with ≥5% bone marrow blast at time of inclusion;
* Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
* ECOG performance status of ≤ 2.

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria:

* Active CNS leukemia;
* Previous treatment with any CD123 targeting therapy;
* Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy;
* Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829;
* History of other malignancy(with certain exceptions);
* Active and uncontrolled infections;
* Unresolved AEs ≥2 Grade, from prior therapies.

The above is a summary, other exclusion criteria details may apply .

Locations (22)

Duarte, California, United States
St Louis, Missouri, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Columbus, Ohio, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
Heidelberg, Australia
Melbourne, Australia
Tianjin, China
Frankfurt, Germany
Bologna, Italy
Kashiwa, Japan
Osaka, Japan
Yoshida-gun, Japan
Seoul, South Korea
Seoul, South Korea
Barcelona, Spain
Salamanca, Spain
Tainan, Taiwan
Taipei, Taiwan
Manchester, United Kingdom