Treatment for newly-diagnosed acute myeloid leukemia with CEBPA double mutations
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
This study is testing a new treatment plan for people with newly-diagnosed acute myeloid leukemia who have specific genetic mutations to see if it helps them stay cancer-free longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 14 Years to 55 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT04415008 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial aims to evaluate the efficacy of a treatment regimen combining homoharringtonine, cytarabine, and daunorubicin (HAD) in patients with newly-diagnosed acute myeloid leukemia (AML) who have CEBPA double mutations. A total of 40 patients will receive the HAD induction regimen, followed by high-dose cytarabine after achieving complete remission. The study will assess event-free and relapse-free survival as primary endpoints, while also exploring genetic mutations and measurable residual disease (MRD) at diagnosis and post-chemotherapy. Risk stratification based on genetic factors and MRD will be investigated to optimize treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are newly-diagnosed AML patients aged 14 to 55 years with CEBPA double mutations and an ECOG performance status of 0-2.
Not a fit: Patients who have received prior chemotherapy for remission induction or have secondary AML or other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and reduce relapse in patients with CEBPA double mutated AML.
How similar studies have performed: While this approach is being tested in this specific context, similar treatment regimens have shown promise in improving outcomes for AML patients, particularly those with specific genetic mutations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tianjin, Tianjin
- Hbdh — Tianjin, Tianjin, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.