NCT06084819 Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
| NCT ID | NCT06084819 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Relapsed/Refractory Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2029-01-31 |
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 200 participants in total. It began in 2023-08-01 with a primary completion date of 2029-01-31.
⚠ 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
The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria: * Patients who are able to understand and willing to sign the informed consent form (ICF). * All patients should aged 14 to 75 years,no gender limitation. * Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA criteria * Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal; * Renal function: creatinine ≤the upper limit of normal; * Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; * The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months. * Patients without severe allergic constitution. Exclusion Criteria: * Patients with allergy or contraindication to the study drug; * Female patients who are pregnant or breast-feeding. * Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment; * Patients with mental illness or other states unable to comply with the protocol; * Less than 6 weeks after surgical operation of important organs. * Liver function: ALT and AST\>2.5 times the upper limit of normal ,bilirubin\>2 times the upper limit of normal;Renal function: creatinine \>the upper limit of normal; * The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)
Contact & Investigator
Daihong Liu, doctor
STUDY CHAIR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT06084819 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 75 Years, studying Relapsed/Refractory 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 NCT06084819 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 NCT06084819 currently recruiting?
Yes, NCT06084819 is actively recruiting participants. Contact the research team at daihongrm@163.com for enrollment information.
Where is the NCT06084819 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06084819 clinical trial?
NCT06084819 is sponsored by Chinese PLA General Hospital. The principal investigator is Daihong Liu, doctor at Chinese PLA General Hospital. The trial plans to enroll 200 participants.
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