Comparing two treatments for elderly patients with acute myeloid leukemia after initial remission
Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation in Comparison to Consolidation Therapy Based Venetoclax for Elderly Patients With Acute Myeloid Leukemia After First CR
This study is testing whether a new drug called venetoclax or a stem cell transplant works better for older patients with acute myeloid leukemia who are in remission but at risk of relapse.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 60 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06571825 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two different consolidation therapies for elderly patients aged 60-75 with acute myeloid leukemia (AML) who have achieved complete remission after induction chemotherapy. One group will receive venetoclax, a BCL-2 inhibitor, while the other will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study aims to determine which treatment strategy offers better outcomes for patients at intermediate to high risk of relapse. It is a prospective, open-label, two-arm, non-randomized study conducted at a single center.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 60-75 with intermediate to high-risk AML who have achieved complete remission after chemotherapy.
Not a fit: Patients who do not meet the age or risk criteria, or those without a suitable stem cell donor, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective consolidation treatment option for elderly AML patients, potentially improving their long-term survival rates.
How similar studies have performed: While the use of venetoclax has shown promise in improving remission rates, this specific comparison of consolidation strategies in elderly AML patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with AML according to the 2022 WHO diagnostic criteria; * Age 60-75 years; * Intermediate to high-risk AML according to the ELN criteria, AML with myelodysplasia-related changes (AML-MRC) or therapy-related AML (t-AML), or core-binding factor AML (CBF-AML) with D816 KIT mutation; or newly diagnosed hypercellular leukemia (WBC ≥ 10×10\^9/L); * Achieved CR or CR with incomplete hematologic recovery (CRi) after one to two courses of induction chemotherapy; * Have a matched related, haploidentical, or mismatched unrelated hematopoietic stem cell donor; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal (ULN), and total bilirubin ≤ 2× ULN; * Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%; Expected survival \> 8 weeks; * Voluntarily signed the informed consent form and can understand and comply with the study's requirements. Exclusion Criteria: * Currently has clinically active cardiovascular disease, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any class 3 or 4 heart disease according to the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 3 months before screening; * Other severe diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure); * Known human immunodeficiency virus (HIV) infection or severe viral hepatitis not controlled by medication; * Pregnant or breastfeeding women; * Unable to understand, comply with the study protocol, or unable to sign the informed consent form.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yanmin Zhao, PhD
- Email: yanminzhao@zju.edu.cn
- Phone: 15858199217
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.