NCT05404906 AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
| NCT ID | NCT05404906 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Acute Myeloid Leukemia (AML) in Remission |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2022-06-25 |
| Primary Completion | 2028-06 |
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 124 participants in total. It began in 2022-06-25 with a primary completion date of 2028-06.
⚠ 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 phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant. 2. Aged 18-64 years. 3. Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission. 4. ECOG performance status of \< or = 3. 5. Adequate organ function as follows: 1. Serum total bilirubin \< or = to 3 X the Upper Limit of Normal (ULN) 2. Aspartate Transaminase and alanine transaminase \< or = to 3 x ULN 3. Ccr（Creatinine Clearance Rate) \> or ＝60 ml/min 4. Left ventricular ejection fraction \> or ＝50% determined by ultrasound. 6. For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling. 7. For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment. 8. Ability to understand and sign informed consent. Exclusion Criteria: 1. Acute promyeloid leukemia. 2. Patients with active central nervous system (CNS) leukemia. 3. Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML. 4. Patients with other progressive malignancies. 5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal). 6. Patients who have participated in other trials within 30 days before signing the informed consent. 7. Females who are pregnant or lactating or intending to become pregnant during the study.
Contact & Investigator
Suning Chen
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT05404906 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Acute Myeloid Leukemia (AML) in Remission. 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 NCT05404906 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 NCT05404906 currently recruiting?
Yes, NCT05404906 is actively recruiting participants. Contact the research team at chensuning@sina.com for enrollment information.
Where is the NCT05404906 trial being conducted?
This trial is being conducted at Suzhou, China, Suzhou, China.
Who is sponsoring the NCT05404906 clinical trial?
NCT05404906 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Suning Chen at First Affiliated Hospital of Soochow University. The trial plans to enroll 124 participants.
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