a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia

Recruiting Phase 2 Interventional Study
Acute Myeloid Leukemia IDH1 Gene Mutation Ivosidenib
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
The First Affiliated Hospital of Soochow University · Other
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About This Trial
This is a single arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of ivosidenib+venetoclax+ azacitidine in adult Chinese subjects with newly diagnosed IDH1m AML.A total of approximately 42 China Nationwide subjects with newly diagnosed IDH1m AML will participate in the study.The primary endpoint of the study is the complete remission(CR) + CR with partial hematologic…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Be ≥18 years of age 2. Have previously untreated AML, defined according to World Health Organization criteria. Subjects with extramedullary disease alone (ie, no detectable bone marrow and no detectable peripheral blood AML) are not eligible for the study. 3. Have an IDHl mut…
Contacts

Su-ning Chen, M.D.

008613814881746

chensuning@sina.com

CONTACT