NCT06621199 Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML
| NCT ID | NCT06621199 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-07-08 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2024-07-08 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).
Eligibility Criteria
Inclusion Criteria: 1. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. 2. Aged 60-70 years (including boundary values 60 and 70); 3. Newly diagnosed primary AML according to the WHO 2022 classification. 4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2. 5. Life expectancy ≥ 3 months. 6. ALT/AST≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN. Exclusion Criteria: 1. Subjects meet any of the following conditions: 1. Acute promyelocytic leukemia; 2. Secondary AML caused by chemotherapy and/or radiotherapy to treat solid tumor or antecedent hematological disorders such as MDS, MPN, MDS/MPN; 3. AML following blast transformation of prior chronic myeloid leukemia; 4. Central nervous system (CNS) leukemia; 2. Subjects with malignant tumors (excluding cured skin basal cell carcinoma, cervical carcinoma in situ, and other malignant tumors that have not been treated and effectively controlled within the past 5 years) within the past 5 years. 3. Subjects who have received anthracycline pretreatment or other anti-AML treatments (except for hydroxyurea, leukapheresis and other leukocyte-lowering treatments); 4. Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment; 5. Subjects who are unable to take oral medications or have malabsorption syndrome; 6. Cardiac function and disease conform to one of the following conditions: 1. Long QTc syndrome or QTc interval \>480 ms; 2. Complete left bundle branch block, degree II or III atrioventricular block; 3. Severe, uncontrolled arrhythmia requiring medical treatment; 4. New York Heart Association(NYHA) classification ≥ grade II; 5. Cardiac ejection fraction (EF) was less than 50%; 6. A history of myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiogram evidence of acute ischemic or active conduction abnormalities within 6 months prior to enrollment; 7. Uncontrolled systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.); 8. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 9. HBsAg or HBcAb positive, with HBV-DNA≥1x10\^3 copies/mL; HCV Ab positive, with HCV-RNA≥1x10\^3 copies/mL; 10. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug. 11. With a history of severe neurological or psychiatric illness. 12. Not suitable for this study as decided by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06621199 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 70 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06621199 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06621199 currently recruiting?
Yes, NCT06621199 is actively recruiting participants. Contact the research team at jiej0503@163.com for enrollment information.
Where is the NCT06621199 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06621199 clinical trial?
NCT06621199 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 42 participants.
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