Clinical trial · Interventional
Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia
A Prospective, Multicenter, Single Arm Clinical Study to Evaluate Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| CEBPA Double Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HAD induction with intermediate dose cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- prospective, open-label, multicenter,single arm
- interventionNames
- Drug: HAD induction with intermediate dose cytarabine
Primary outcomes (2)
- measure
- event free survival
- timeFrame
- 5 years
- description
- Measured from day 1 of randomization to the date of treatment failure, hematologic relapse from CR or death from any cause, whichever occurs first
- measure
- relapse free survival
- timeFrame
- 5 years
- description
- survival from complete remission to relapse
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * newly-diagnosed of acute myeloid leukemia except acute promyelocytic leukemia * with CEBPA double mutation * age≥ 14 years and\<55 years，male or female * ECOG-PS score 0-2 * laboratory tests（within 7 days before chemotherapy） 1. serum total bilirubin≤1.5xULN； 2. serum AST and ALT≤2.5xULN 3. serum creatinine≤2xULN； 4. cardiac enzymes≤2xULN 5. ejection fraction \>50% by ECHO。 * written informed consent。 Exclusion Criteria: * subject has received remission induction chemotherapy * secondary AML * with other hematological malignancy * with other tumors(needing treatment) * pregnant or lactating women * active heart diseases * severe active infection * unfit for enrollment evaluated by investigator
References
Publications (0)
Data not yet available