NCT06990321 Effectiveness of Medium-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Intermediate to High-Risk Acute Myeloid Leukemia
| NCT ID | NCT06990321 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Yehui Tan |
| Condition | Acute Myeloid Leukemia (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-12-31 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 68 participants in total. It began in 2025-06-01 with a primary completion date of 2026-12-31.
⚠ 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
A Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination with Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in the Elderly
Eligibility Criteria
Inclusion Criteria: 1.Age ≥ 60 years and ≤ 75 years, regardless of gender; 2.Diagnosed with AML (acute myeloid leukemia) according to WHO criteria (non-acute promyelocytic leukemia); 3.Risk stratification as intermediate or high risk based on the ELN (2022) guidelines; 4.Expected survival time ≥ 3 months; 5.Not suitable for allogeneic hematopoietic stem cell transplantation; 6.AML patients who achieve remission with morphologic assessment of bone marrow showing no leukemic involvement after induction therapy; 7.Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2; 8.Meeting the following laboratory requirements (performed within 7 days prior to treatment): 1. Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group; 2. AST and ALT ≤ 2.5 times the upper limit of normal for the same age group; 3. Serum creatinine \< 2 times the upper limit of normal for the same age group; 4. Cardiac ejection fraction within normal limits as determined by echocardiogram. 9.Able to comply with the study visit schedule and understand and adhere to all trial protocol requirements; 10.Able to take oral medications. Exclusion Criteria: Subjects who meet any of the following criteria shall not be included in this study: 1. Allergic to any drugs included in the trial protocol or drugs with a chemical structure similar to the investigational drug. 2. Chemotherapy intolerance assessed by Ferrara 2013 criteria prior to enrollment. 3. Hematologic relapse (bone marrow blasts or immature cells exceed 5%). 4. Simultaneous diagnosis of other malignant tumors in organs (requiring treatment). 5. Known or suspected drug abuse or alcohol dependence. 6. Mental illness or any condition that prevents obtaining informed consent, or inability to comply with the study treatment and examination requirements. 7. Liver dysfunction (total bilirubin \>1.5×ULN, ALT/AST \>2.5×ULN, or liver-involved patients with ALT/AST \>5×ULN), kidney dysfunction (serum creatinine \>1.5×ULN). 8. Active heart disease, defined as one or more of the following: 1\) History of uncontrolled or symptomatic angina. 2) Myocardial infarction within 6 months prior to enrollment. 3) History of arrhythmias requiring drug treatment or with severe clinical symptoms. 4\) Uncontrolled or symptomatic congestive heart failure (\>NYHA class 2). 5) Ejection fraction below the lower limit of normal. 9.Participation in another clinical trial within 30 days. 10.Active infection. 11.The investigator deems the subject unfit for participation in this trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06990321 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 75 Years, studying Acute Myeloid Leukemia (AML). 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 NCT06990321 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 68 participants.
Is NCT06990321 currently recruiting?
Yes, NCT06990321 is actively recruiting participants. Contact the research team at yhtan@jlu.edu.cn for enrollment information.
Where is the NCT06990321 trial being conducted?
This trial is being conducted at Changchun, China.
Who is sponsoring the NCT06990321 clinical trial?
NCT06990321 is sponsored by Yehui Tan. The trial plans to enroll 68 participants.
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