Comparing chemotherapy regimens for elderly patients with newly diagnosed AML
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
NA · Institute of Hematology & Blood Diseases Hospital, China · NCT06066242
This study is testing three different chemotherapy treatments to see which one works best for older patients aged 60 to 75 who have just been diagnosed with acute myeloid leukemia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 60 Years to 75 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06066242 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify the optimal induction chemotherapy regimen for elderly patients aged 60 to 75 who are newly diagnosed with acute myeloid leukemia (AML) and are eligible for intensive chemotherapy. It will be a multicenter, randomized, controlled trial comparing three different induction regimens: Ven+AZA, DA/IA 3+7, and DA/IA 2+5+VEN. A total of 90 patients will be enrolled and divided into three groups, with those achieving complete remission receiving standardized consolidation and maintenance therapy. The study will also recommend allogeneic hematopoietic stem cell transplantation for high-risk patients or those with minimal residual disease positivity.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 to 75 who are newly diagnosed with acute myeloid leukemia and are fit for intensive chemotherapy.
Not a fit: Patients with acute promyelocytic leukemia or specific genetic mutations related to AML may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for elderly AML patients, improving their chances of remission.
How similar studies have performed: While there have been studies on chemotherapy regimens for AML, this specific comparison in elderly patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able to understand the study and voluntarily sign informed consent. 2. Age: 60\~75 years old, gender unlimited. 3. 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. 4. Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2. 5. Fit for intensive chemotherapy. 6. 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 Exclusion Criteria: 1. Patients with acute promyelocytic leukemia 2. Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene 3. Patients with BCR::ABL fusion gene 4. Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before. 5. Patients with concurrent malignant tumors requiring treatment 6. 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. 7. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
Where this trial is running
Tianjin
- Institute of Hematology & Blood Diseases Hospital — Tianjin, China (RECRUITING)
Study contacts
- Principal investigator: Hui Wei, MD — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Hui Wei, MD
- Email: weihui@ihcams.ac.cn
- Phone: 86-022-23909020
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.
Conditions: Acute Myeloid Leukemia, elderly, newly diagnosed, fit, induction regimen