NCT04415008Active, not recruitingPhase 2
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 · Last updated 3 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 31 May 2020
- Start date
- 1 Jun 2020
- Primary completion date
- 3 Oct 2026
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT04415008
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 61
- From 1 Jun 2020 to the primary completion date, 3 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- subject has received remission induction chemotherapy
Other illness
- with other hematological malignancy
- active heart diseases
- severe active infection
Other
- secondary AML
- with other tumors(needing treatment)
- pregnant or lactating women
- unfit for enrollment evaluated by investigator
Who the study is looking for
- 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）
- serum total bilirubin≤1.5xULN；
- serum AST and ALT≤2.5xULN
- serum creatinine≤2xULN；
- cardiac enzymes≤2xULN
- ejection fraction \>50% by ECHO。
- written informed consent。
Age in the registry: 14 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HBDH Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.