NCT07108530RecruitingPhase 2
Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study
Integrated Treatment Protocol for Induction/Consolidation Chemotherapy and Transplantation in Adult Acute Myeloid Leukemia Multicenter Study on the Efficacy of an Integrated Treatment Approach
Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 1 Jul 2025
- Start date
- 6 Aug 2025
- Primary completion date
- 6 Aug 2027
- Lead sponsor
- Shanxi Bethune Hospital
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07108530
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 6 Aug 2025 to the primary completion date, 6 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of intracranial hemorrhage;
- Psychiatric illness or other conditions precluding protocol adherence;
Lab values
- Severe cardiac arrhythmia, abnormal ECG (QTc \>500 ms).
Other
- Pregnancy;
Who the study is looking for
- 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.
Age in the registry: 14 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.