drugset / Trial / NCT04415008

Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia

NCT04415008

Phase 2 Active not recruiting 61 enrolled Institute of Hematology & Blood Diseases Hospital, China
NaSingle-groupOpen-labelTreatment

Summary

Acute myeloid leukemia is a heterogenous hematological malignancy, characterized by different cytogenetic or molecular features. CEBPA double mutation acute myeloid leukemia (CEBPAdm AML)has favourite prognosis, especially in younger adult patients. But cumulative incidence of relapse of this group patients is still high, so the treatment options need to be optimized urgently.HAD(homoharringtonine(HHT)+cytarabine+daunorubicin) with intermediate dose cytarabine improved the survival of AML, especially in patients with CEBPA double mutation.

Timeline

Start
2020-06-01
Primary completion
2026-10-03
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 100 mg/m2
Subject Cytarabine Small molecule 1 g
Subject Cytarabine Small molecule 3 g
Subject Daunorubicin Small molecule 40 mg/m2
Subject Homoharringtonine Small molecule 2 mg/m2