Tests a combined chemotherapy and transplant plan in adults with acute myeloid leukemia
Tests a combined chemotherapy and stem cell transplant plan in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study
Key facts
- Where
- Taiyuan, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults and teenagers with newly diagnosed acute myeloid leukemia (not the M3 type) who can have chemotherapy followed by a stem cell transplant.
- Age
- 14 years to 65 years
- Sex
- All sexes can join
- Disease stage
- Acute myeloid leukemia (AML), not the M3 type (acute promyelocytic leukemia). Low-risk, intermediate-risk and high-risk disease can join. Bone marrow must show hypercellularity or hypocellularity. Newly diagnosed.
Main reasons for not taking part
- Acute promyelocytic leukemia (AML-M3)
- Bleeding inside the skull (intracranial hemorrhage)
- Pregnancy
- Psychiatric illness or other conditions that prevent following the trial plan
- Severe heart rhythm problem or abnormal ECG (QTc >500 ms)
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 65 years old?
Source: NCT07108530, who can take part
Where in China
- Shanxi Bethune HospitalTaiyuan, ChinaContact: Tao Wang, Dr.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanxi Bethune Hospital
- Trial code
- NCT07108530
- Record updated
- 7 August 2025
- Original description
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.Read full original descriptionShow less
Integrated Treatment Protocol for Induction/Consolidation Chemotherapy and Transplantation in Adult Acute Myeloid Leukemia Multicenter Study on the Efficacy of an Integrated Treatment Approach
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.
Inclusion: 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: Presence of intracranial hemorrhage; Psychiatric illness or other conditions precluding protocol adherence; Severe cardiac arrhythmia, abnormal ECG (QTc >500 ms); Pregnancy.