NCT07108530 Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study
| NCT ID | NCT07108530 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanxi Bethune Hospital |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2027-08-06 |
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 50 participants in total. It began in 2025-08-06 with a primary completion date of 2027-08-06.
⚠ 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 is a multicenter, single-arm, open-label clinical study designed to evaluate the efficacy and safety of an integrated "induction-consolidation-transplantation" treatment protocol in adult patients with acute myeloid leukemia (AML, excluding M3 subtype). Based on patients' economic conditions, two induction regimens are offered: the IAV regimen (idarubicin + cytarabine + venetoclax) for those with better financial resources, and the DAV regimen (daunorubicin + cytarabine + venetoclax) for those with limited resources. During the consolidation phase, patients receive either the MA regimen (liposomal mitoxantrone + intermediate-dose cytarabine) or intermediate-dose cytarabine monotherapy. Eligible patients proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a FA-BuCy/ATG conditioning regimen and an innovative graft-versus-host disease (GVHD) prophylaxis strategy using anti-CD25 monoclonal antibody combined with delayed oral cyclosporine. The entire treatment plan is designed to be completed within four months of diagnosis. The study plans to enroll 50 newly diagnosed patients aged 14-65 years. Primary endpoints include disease-free survival (DFS), complete remission rate (CR/CRi), and the efficacy of the transplantation protocol. Secondary endpoints include relapse rate, treatment-related mortality, 2-year overall survival, and treatment safety. This study aims to explore a new strategy to improve the cure rate of AML by optimizing drug combinations and shortening the treatment duration.
Eligibility Criteria
Inclusion Criteria: * Age: 14 years - 65 years; * Excluding AML-M3 (Acute Promyelocytic Leukemia) patients; * Diagnosis conforming to the Chinese Diagnosis and Treatment Guidelines for Adult Acute Myeloid Leukemia (Non-APL) (2023 Edition), including low-risk, intermediate-risk, and high-risk patients; * Bone marrow morphology indicating hypercellularity or hypocellularity; * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2. Exclusion Criteria: * Presence of intracranial hemorrhage; * Pregnancy; * Psychiatric illness or other conditions precluding protocol adherence; * Severe cardiac arrhythmia, abnormal ECG (QTc \>500 ms).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07108530 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 65 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 NCT07108530 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 NCT07108530 currently recruiting?
Yes, NCT07108530 is actively recruiting participants. Contact the research team at wangtao99699@163.com for enrollment information.
Where is the NCT07108530 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT07108530 clinical trial?
NCT07108530 is sponsored by Shanxi Bethune Hospital. The trial plans to enroll 50 participants.
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