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NCT04415008

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

Active, enrolled Phase 2 Last updated 3 June 2025
What this trial tests

Phase 2 trial testing HAD induction with intermediate dose cytarabine in CEBPA Double Mutation in 61 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 June 2020
Primary endpoint
3 October 2026
1 June 2027

Quick facts

Lead sponsorInstitute of Hematology & Blood Diseases Hospital, China
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment61
Start date1 June 2020
Primary completion3 October 2026
Estimated completion1 June 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Who can join

Adults 14 to 55, any sex, with CEBPA Double Mutation or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. What Does the Economic Burden of Acute Myeloid Leukemia Treatment Look Like for the Next Decade? An Analysis of Key Findings, Challenges and Recommendations.
    Forsythe A, Sandman K. · · 2021 · cited 16× · PMID 33981169 · DOI 10.2147/jbm.s279736

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