NCT06066242Active, not recruiting
Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy
Optimizing Induction Chemotherapy Regimens for Newly Diagnosed Elderly Acute Myeloid Leukemia Patients Who Are Eligible for Intense Chemotherapy: A Multicenter, Randomized, Controlled Phase II Clinical Trial
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to screen the safety and efficacy of two induction regimens (Ven+AZA and DA/IA 2+5+VEN) in order to select one as the experimental arm in the sebsequent 3 phase RCT study. A total of 90 patients will be enrolled in this study and segregated into three groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 113 (actual)
- First submitted
- 27 Sept 2023
- Start date
- 1 Oct 2023
- Primary completion date
- 20 Oct 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06066242
What you commit to
- Study type: Interventional
- Participants enrolled: 113
- From 1 Oct 2023 to the primary completion date, 20 Oct 2027
- 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
- Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before.
- Patients with concurrent malignant tumors requiring treatment
Other illness
- Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
Lab values
- Patients with active heart disease defined as one or more of the following: (1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA\> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range.
Other
- Patients with acute promyelocytic leukemia
- Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene
- Patients with BCR::ABL fusion gene
Who the study is looking for
- Able to understand the study and voluntarily sign informed consent.
- Age: 60\~75 years old, gender unlimited.
- Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.
- Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2.
- Fit for intensive chemotherapy.
- The function of main organs should meet the following standards before treatment: Kidney: serum creatinine ≤ 2× upper limit of normal range (ULN); Liver: total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5× ULN; Heart: myocardial enzymes ≤ 2× ULN and normal ejection fraction by cardiac color doppler ultrasound
Age in the registry: 60 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.