NCT05805098 Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML
| NCT ID | NCT05805098 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2025-03-01 |
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 60 participants in total. It began in 2023-03-01 with a primary completion date of 2025-03-01.
⚠ 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 study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria: 1. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent. 2. patients must have confirmation of AML by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance \< 45 mL/min. Moderate hepatic impairment with total bilirubin \> 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy. 3. Patients \> 18 to ≤ 60 years 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2 5. Laboratory values meeting the following criteria:Creatinine clearance ≥ 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Serum aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN) 、Serum alanine aminotransferase (ALT) ≤ 3.0 × ULN (Unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, White blood cell (WBC) count \< 25 × 109 /L (hydroxyurea is permitted to meet this criterion) Exclusion Criteria: 1. \> 60 years of age or \<18 years of age 2. Acute promyelocytic leukemia (M3) 3. Patient is ineligible for treatment with intensive chemotherapy 4. Patient with active infection not controlled, active bleeding from vital organs 5. Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study 6. Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study. 7. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen. 8. Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C 9. Patients deemed unsuitable for enrolment by the investigator.
Contact & Investigator
Huiying Qiu, PhD
STUDY CHAIR
The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT05805098 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 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 NCT05805098 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 NCT05805098 currently recruiting?
Yes, NCT05805098 is actively recruiting participants. Contact the research team at qiuhuiying@aliyun.com for enrollment information.
Where is the NCT05805098 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT05805098 clinical trial?
NCT05805098 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Huiying Qiu, PhD at The First Affiliated Hospital of Soochow University. The trial plans to enroll 60 participants.
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