a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia

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 recovery(CRh) rate, and the key secondary endpoints are CR rate,event-free survival (EFS),overall survival (OS),the objective response rate (ORR).

Trial Details

NCT ID
NCT07007949
Phase
PHASE2
Sponsor
The First Affiliated Hospital of Soochow University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Ivosidenib combined with venetoclax and azacitidine
Locations (sample)
  • Suzhou, Jiangsu, China|31.30408,120.59538

Key Eligibility Criteria

  • Be ≥18 years of age
  • Have previously untreated AML, defined according to World Health Organization criteria. Subjects with extramedullary disease alone (ie, no detectab…
  • Have an IDHl mutation resulting in an R132C, R132G, R132H, R132L, or R132S substitution.
  • Have an ECOG PS score of 0 to 2.

For full eligibility, visit ClinicalTrials.gov.

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