NCT06571825RecruitingPhase 4
RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation in Comparison to Consolidation Therapy Based Venetoclax for Elderly Patients With Acute Myeloid Leukemia After First CR
Source: ClinicalTrials.gov · Last updated 26 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Elderly patients with acute myeloid leukemia (AML) often face unfavorable prognostic factors such as multiple comorbidities, adverse cytogenetic profiles, and pre-existing hematological disorders. The long-term survival rate remains very low, with a 5-year survival rate of only 5% to 10%. The introduction of the BCL-2 inhibitor venetoclax (Ven) has improved the induction remission rates in elderly patients. However, the question of whether to use chemotherapy maintenance or proceed with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for post-remission consolidation therapy remains unclear due to the lack of prospective controlled studies. Therefore, our center plans to conduct a prospective, open-label, two-arm, non-randomized, single-center study to further explore the optimal consolidation treatment strategy for elderly AML patients at intermediate and high risk following induction complete remission (CR).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 20 Aug 2024
- Start date
- 17 Jul 2024
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- He Huang
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06571825
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 118
- From 17 Jul 2024 to the primary completion date, 30 Dec 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
- 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 illness
- 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;
Other
- Pregnant or breastfeeding women;
- Unable to understand, comply with the study protocol, or unable to sign the informed consent form.
Who the study is looking for
- 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.
Age in the registry: 60 years to 75 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 |
|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.