Acute Myeloid LeukemiaPhase 2NCT07108530
Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study
A Phase 2 study testing Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML, First Induction (IAV or DAV Regimen) and Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen in people with Acute Myeloid Leukemia, run by Shanxi Bethune Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML, First Induction (IAV or DAV Regimen) and Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2025to 6 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of intracranial hemorrhage;
- Pregnancy;
- Psychiatric illness or other conditions precluding protocol adherence;
- Severe cardiac arrhythmia, abnormal ECG (QTc >500 ms).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
Tao Wang, Dr., 13835175119, wangtao99699@163.com
About this study
Official title: 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.
Read the detailed description
Intervention Measures
- Induction and Consolidation Treatment Regimen 1.1 First Induction Therapy: IAV or DAV Regimen
- IAV Regimen:Intravenous Idarubicin (Ida): 6 mg/m²/day on days 1-3 (total cumulative dose ≤ 40 mg)，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11）
- DAV Regimen：Intravenous Daunorubicin (D): 60 mg/m²/day on days 1-3，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11） 1.2 Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen
- MA Regimen (Liposomal Mitoxantrone + Intermediate-Dose Cytarabine):Liposomal Mitoxantrone: 10 mg/m²/day on days 1-2.Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3).
- Intermediate-Dose Cytarabine Regimen:Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3). Summary:
- For patients with good economic conditions: IAV → MA regimen.
- For patients with limited economic resources: DAV → Intermediate-dose cytarabine regimen.
- Subsequent Treatment Plan for Transplant-Eligible Patients Patients eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT) should proceed directly to transplant after the above two treatment cycles（The requirement before transplantation is that minimal residual disease should be negative).
- Conditioning Regimen: FA + BuCy (Fludarabine + Busulfan + Cyclophosphamide). For haploidentical transplantation, ATG (antithymocyte globulin) is added.
- Donor Selection Priority:
- HLA-matched sibling donor (MSD) 2. Matched unrelated donor (MUD) 3. Haploidentical donor (Haplo) Selection should consider donor age, health status, and other clinical factors. 3.Allogeneic Stem Cell Transplantation Protocol 3.1 Conditioning Regimen: FA-BuCy/ATG
- Fludarabine: 30 mg/m²/day on days -8 to -6
- Cytarabine: 1 g/m²/day on days -8 to -6
- Busulfan: 2.4 mg/kg/day on days -5 to -3
- Cyclophosphamide: 30 mg/kg/day on days -4 to -3
- ATG (Antithymocyte Globulin): 7.5 mg/kg total dose, administered from day -5 to -2 3.2 GVHD Prophylaxis
- Recombinant Humanized Anti-CD25 Monoclonal Antibody: 50 mg on days +1 and +4.
- The GVHD prophylaxis regimen consists of cyclosporine, mycophenolate mofetil (MMF), and short-course methotrexate (MTX).Cyclosporine (CsA):Initiated as a continuous 24-hour intravenous infusion at a dose of 2 mg/kg/day, starting from day -9 before transplantation.Once the patient can tolerate oral intake, cyclosporine is switched to oral administration at a dose of 3-5 mg/kg/day, divided into two daily doses.The target therapeutic trough concentration of cyclosporine should be maintained between 150-250 μg/L.
- Delayed Oral Cyclosporine Protocol:Continue IV infusion until day +20, even if GI symptoms resolve.Switch to oral only if no acute GVHD occurs.If grade II-IV acute GVHD develops, continue IV CsA. 4.Subsequent Treatment for Patients Unsuitable for or Declining Transplantation 4.1 Consolidation Therapy (Two Cycles)
- Option A Intermediate-Dose Cytarabine-Based Regimen：Liposomal Mitoxantrone: 10 mg/day on days 1-2 (dose-reduced).Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3).
- Option B VA Regimen (Venetoclax + Azacitidine)：Venetoclax (V): Dose-escalation starting at 100 mg on day 1, increasing to 400 mg/day by day 6, continued through day 14.Azacitidine (A): 75 mg/m²/day subcutaneously or intravenously on days 1-7.
- Treatment Cycle:Each regimen is administered for two cycles with a 3-week interval between cycles, followed by maintenance therapy.
4.2 Maintenance Therapy After Two Consolidation Cycles
- Pegylated Interferon α-2b (Long-acting Interferon): 180μg subcutaneously every two weeks.
Continued until disease progression or unacceptable toxicity occurs.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML, First Induction (IAV or DAV Regimen), Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen, Subsequent Treatment Plan for Transplant-Eligible Patients, Allogeneic Stem Cell Transplantation Protocol
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AMLOther
This intervention is distinguished by its risk-adapted, time-compressed, and economically tiered design. It integrates two induction options-IAV (idarubicin + cytarabine + venetoclax) for patients with better economic resources and DAV (daunorubicin + cytarabine + venetoclax) for those with limited resources-followed by consolidation with either the MA regimen (liposomal mitoxantrone + intermediate-dose cytarabine) or intermediate-dose cytarabine alone. Eligible patients proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a FA-BuCy/ATG conditioning regimen and a novel GVHD prophylaxis strategy using anti-CD25 monoclonal antibody combined with delayed oral cyclosporine. The entire treatment is designed to be completed within four months from diagnosis. This protocol is unique in its combination of liposomal chemotherapy, venetoclax-based induction, and tailored transplant strategies.
First Induction (IAV or DAV Regimen)Drug
- IAV Regimen:Intravenous Idarubicin (Ida): 6 mg/m²/day on days 1-3 (total cumulative dose ≤ 40 mg)，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11）
- DAV Regimen：Intravenous Daunorubicin (D): 60 mg/m²/day on days 1-3，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11）
Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine RegimenDrug
- MA Regimen (Liposomal Mitoxantrone + Intermediate-Dose Cytarabine):Liposomal Mitoxantrone: 10 mg/m²/day on days 1-2.Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3).
- Intermediate-Dose Cytarabine Regimen:Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3).
Subsequent Treatment Plan for Transplant-Eligible PatientsOther
Patients eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT) should proceed directly to transplant after the above two treatment cycles（The requirement before transplantation is that minimal residual disease should be negative).
- Conditioning Regimen: FA + BuCy (Fludarabine + Busulfan + Cyclophosphamide). For haploidentical transplantation, ATG (antithymocyte globulin) is added.
- Donor Selection Priority:
- HLA-matched sibling donor (MSD)
- Matched unrelated donor (MUD)
- Haploidentical donor (Haplo) Selection should consider donor age, health status, and other clinical factors.
Allogeneic Stem Cell Transplantation ProtocolOther
Conditioning Regimen: FA-BuCy/ATG
- Fludarabine: 30 mg/m²/day on days -8 to -6
- Cytarabine: 1 g/m²/day on days -8 to -6
- Busulfan: 2.4 mg/kg/day on days -5 to -3
- Cyclophosphamide: 30 mg/kg/day on days -4 to -3
- ATG (Antithymocyte Globulin): 7.5 mg/kg total dose, administered from day -5 to -2
GVHD Prophylaxis RegimenOther
GVHD Prophylaxis
- Recombinant Humanized Anti-CD25 Monoclonal Antibody: 50 mg on days +1 and +4.
- The GVHD prophylaxis regimen consists of cyclosporine, mycophenolate mofetil (MMF), and short-course methotrexate (MTX).Cyclosporine (CsA):Initiated as a continuous 24-hour intravenous infusion at a dose of 2 mg/kg/day, starting from day -9 before transplantation.Once the patient can tolerate oral intake, cyclosporine is switched to oral administration at a dose of 3-5 mg/kg/day, divided into two daily doses.The target therapeutic trough concentration of cyclosporine should be maintained between 150-250 μg/L.
- Delayed Oral Cyclosporine Protocol:Continue IV infusion until day +20, even if GI symptoms resolve.Switch to oral only if no acute GVHD occurs.If grade II-IV acute GVHD develops, continue IV CsA.
Subsequent Consolidation Therapy for Transplant-Ineligible PatientsOther
- Consolidation Therapy (Two Cycles)
- Option A Intermediate-Dose Cytarabine-Based Regimen：Liposomal Mitoxantrone: 10 mg/day on days 1-2 (dose-reduced).Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3).
- Option B VA Regimen (Venetoclax + Azacitidine)：Venetoclax (V): Dose-escalation starting at 100 mg on day 1, increasing to 400 mg/day by day 6, continued through day 14.Azacitidine (A): 75 mg/m²/day subcutaneously or intravenously on days 1-7.
- Treatment Cycle:Each regimen is administered for two cycles with a 3-week interval between cycles, followed by maintenance therapy.
- Maintenance Therapy After Two Consolidation Cycles
- Pegylated Interferon α-2b (Long-acting Interferon): 180μg subcutaneously every two weeks.
Continued until disease progression or unacceptable toxicity occurs.
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel | Experimental | Not described Receives: Other: Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML; Drug: First Induction (IAV or DAV Regimen); Drug: Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen; Other: Subsequent Treatment Plan for Transplant-Eligible Patients; Other: Allogeneic Stem Cell Transplantation Protocol; Other: GVHD Prophylaxis Regimen; Other: Subsequent Consolidation Therapy for Transplant-Ineligible Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Measured: 24 months
The Complete Response (CR) rate
The Complete Response (CR) rate refers to the proportion of patients achieving complete remission in a treatment regimen.
Measured: 24 months
Partial Response (PR) rate
The Partial Response (PR) rate in oncology indicates the proportion of patients experiencing a significant reduction in tumor size post-treatment.
Measured: 24 months
No Remission (NR)
Non-Response (NR) in medicine refers to the lack of therapeutic response, indicating no significant improvement in a patient's condition post-treatment.
Measured: 24 months
CR with incomplete hematologic recovery (CRi)
Measured: 24 months
Therapeutic efficacy
The efficacy of the preparative regimen and anti-GVHD regimen for allogeneic stem cell transplantation in AML patients.
Measured: 24 months
Secondary outcomes (5)
Treatment-Related Mortality (TRM)
Measured: 24 months
Overall Survival (OS)
Measured: 24 months
Event-Free Survival (EFS)
Measured: 24 months
Therapeutic efficacy
The therapeutic efficacy of the integrated protocol, especially for high-risk AML patients (e.g., those harboring FLT3-ITD, IDH1, TP53 mutations, complex karyotype) without the use of targeted agents.
Measured: 24 months
Adverse Event
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start6 Aug 2025
- Primary completion6 Aug 2027 (estimated)
- Study completion6 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108530
- Sponsor's protocol ID
- ShanxiBethuneH2
- Status last verified
- Jun 2025
- First submitted
- 1 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Treatment Protocol for Induction/Consolidation Chemotherapy and Transplantation in Adult Acute Myeloid Leukemia Multicenter Study on the Efficacy of an Integrated Treatment Approach
- ClinicalTrials.gov ID
- NCT07108530
- Acronym / sponsor ID
- ShanxiBethuneH2
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 6 Aug 2027 (estimated)
- Study completion
- 6 Aug 2027 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intervention Measures
- Induction and Consolidation Treatment Regimen 1.1 First Induction Therapy: IAV or DAV Regimen
- IAV Regimen:Intravenous Idarubicin (Ida): 6 mg/m²/day on days 1-3 (total cumulative dose ≤ 40 mg)，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11）
- DAV Regimen：Intravenous Daunorubicin (D): 60 mg/m²/day on days 1-3，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11） 1.2 Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen
- MA Regimen (Liposomal Mitoxantrone + Intermediate-Dose Cytarabine):Liposomal Mitoxantrone: 10 mg/m²/day on days 1-2.Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3).
- Intermediate-Dose Cytarabine Regimen:Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3). Summary:
- For patients with good economic conditions: IAV → MA regimen.
- For patients with limited economic resources: DAV → Intermediate-dose cytarabine regimen.
- Subsequent Treatment Plan for Transplant-Eligible Patients Patients eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT) should proceed directly to transplant after the above two treatment cycles（The requirement before transplantation is that minimal residual disease should be negative).
- Conditioning Regimen: FA + BuCy (Fludarabine + Busulfan + Cyclophosphamide). For haploidentical transplantation, ATG (antithymocyte globulin) is added.
- Donor Selection Priority:
- HLA-matched sibling donor (MSD) 2. Matched unrelated donor (MUD) 3. Haploidentical donor (Haplo) Selection should consider donor age, health status, and other clinical factors. 3.Allogeneic Stem Cell Transplantation Protocol 3.1 Conditioning Regimen: FA-BuCy/ATG
- Fludarabine: 30 mg/m²/day on days -8 to -6
- Cytarabine: 1 g/m²/day on days -8 to -6
- Busulfan: 2.4 mg/kg/day on days -5 to -3
- Cyclophosphamide: 30 mg/kg/day on days -4 to -3
- ATG (Antithymocyte Globulin): 7.5 mg/kg total dose, administered from day -5 to -2 3.2 GVHD Prophylaxis
- Recombinant Humanized Anti-CD25 Monoclonal Antibody: 50 mg on days +1 and +4.
- The GVHD prophylaxis regimen consists of cyclosporine, mycophenolate mofetil (MMF), and short-course methotrexate (MTX).Cyclosporine (CsA):Initiated as a continuous 24-hour intravenous infusion at a dose of 2 mg/kg/day, starting from day -9 before transplantation.Once the patient can tolerate oral intake, cyclosporine is switched to oral administration at a dose of 3-5 mg/kg/day, divided into two daily doses.The target therapeutic trough concentration of cyclosporine should be maintained between 150-250 μg/L.
- Delayed Oral Cyclosporine Protocol:Continue IV infusion until day +20, even if GI symptoms resolve.Switch to oral only if no acute GVHD occurs.If grade II-IV acute GVHD develops, continue IV CsA. 4.Subsequent Treatment for Patients Unsuitable for or Declining Transplantation 4.1 Consolidation Therapy (Two Cycles)
- Option A Intermediate-Dose Cytarabine-Based Regimen：Liposomal Mitoxantrone: 10 mg/day on days 1-2 (dose-reduced).Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3).
- Option B VA Regimen (Venetoclax + Azacitidine)：Venetoclax (V): Dose-escalation starting at 100 mg on day 1, increasing to 400 mg/day by day 6, continued through day 14.Azacitidine (A): 75 mg/m²/day subcutaneously or intravenously on days 1-7.
- Treatment Cycle:Each regimen is administered for two cycles with a 3-week interval between cycles, followed by maintenance therapy.
4.2 Maintenance Therapy After Two Consolidation Cycles
- Pegylated Interferon α-2b (Long-acting Interferon): 180μg subcutaneously every two weeks.
Continued until disease progression or unacceptable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel | Experimental | Other: Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML, Drug: First Induction (IAV or DAV Regimen), Drug: Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen, Other: Subsequent Treatment Plan for Transplant-Eligible Patients, Other: Allogeneic Stem Cell Transplantation Protocol, Other: GVHD Prophylaxis Regimen, Other: Subsequent Consolidation Therapy for Transplant-Ineligible Patients |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Presence of intracranial hemorrhage;
- Pregnancy;
- Psychiatric illness or other conditions precluding protocol adherence;
- Severe cardiac arrhythmia, abnormal ECG (QTc >500 ms).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AMLThis intervention is distinguished by its risk-adapted, time-compressed, and economically tiered design. It integrates two induction options-IAV (idarubicin + cytarabine + venetoclax) for patients with better economic resources and DAV (daunorubicin + cytarabine + venetoclax) for those with limited resources-followed by consolidation with either the MA regimen (liposomal mitoxantrone + intermediate-dose cytarabine) or intermediate-dose cytarabine alone. Eligible patients proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a FA-BuCy/ATG conditioning regimen and a novel GVHD prophylaxis strategy using anti-CD25 monoclonal antibody combined with delayed oral cyclosporine. The entire treatment is designed to be completed within four months from diagnosis. This protocol is unique in its combination of liposomal chemotherapy, venetoclax-based induction, and tailored transplant strategies. | Other | Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel |
| First Induction (IAV or DAV Regimen)* IAV Regimen:Intravenous Idarubicin (Ida): 6 mg/m²/day on days 1-3 (total cumulative dose ≤ 40 mg)，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11） * DAV Regimen：Intravenous Daunorubicin (D): 60 mg/m²/day on days 1-3，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11） | Drug | Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel |
| Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen* MA Regimen (Liposomal Mitoxantrone + Intermediate-Dose Cytarabine):Liposomal Mitoxantrone: 10 mg/m²/day on days 1-2.Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3). * Intermediate-Dose Cytarabine Regimen:Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3). | Drug | Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel |
| Subsequent Treatment Plan for Transplant-Eligible PatientsPatients eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT) should proceed directly to transplant after the above two treatment cycles（The requirement before transplantation is that minimal residual disease should be negative). * Conditioning Regimen: FA + BuCy (Fludarabine + Busulfan + Cyclophosphamide). For haploidentical transplantation, ATG (antithymocyte globulin) is added. * Donor Selection Priority: 1. HLA-matched sibling donor (MSD) 2. Matched unrelated donor (MUD) 3. Haploidentical donor (Haplo) Selection should consider donor age, health status, and other clinical factors. | Other | Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel |
| Allogeneic Stem Cell Transplantation ProtocolConditioning Regimen: FA-BuCy/ATG * Fludarabine: 30 mg/m²/day on days -8 to -6 * Cytarabine: 1 g/m²/day on days -8 to -6 * Busulfan: 2.4 mg/kg/day on days -5 to -3 * Cyclophosphamide: 30 mg/kg/day on days -4 to -3 * ATG (Antithymocyte Globulin): 7.5 mg/kg total dose, administered from day -5 to -2 | Other | Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel |
| GVHD Prophylaxis RegimenGVHD Prophylaxis * Recombinant Humanized Anti-CD25 Monoclonal Antibody: 50 mg on days +1 and +4. * The GVHD prophylaxis regimen consists of cyclosporine, mycophenolate mofetil (MMF), and short-course methotrexate (MTX).Cyclosporine (CsA):Initiated as a continuous 24-hour intravenous infusion at a dose of 2 mg/kg/day, starting from day -9 before transplantation.Once the patient can tolerate oral intake, cyclosporine is switched to oral administration at a dose of 3-5 mg/kg/day, divided into two daily doses.The target therapeutic trough concentration of cyclosporine should be maintained between 150-250 μg/L. * Delayed Oral Cyclosporine Protocol:Continue IV infusion until day +20, even if GI symptoms resolve.Switch to oral only if no acute GVHD occurs.If grade II-IV acute GVHD develops, continue IV CsA. | Other | Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel |
| Subsequent Consolidation Therapy for Transplant-Ineligible Patients1. Consolidation Therapy (Two Cycles) * Option A Intermediate-Dose Cytarabine-Based Regimen：Liposomal Mitoxantrone: 10 mg/day on days 1-2 (dose-reduced).Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3). * Option B VA Regimen (Venetoclax + Azacitidine)：Venetoclax (V): Dose-escalation starting at 100 mg on day 1, increasing to 400 mg/day by day 6, continued through day 14.Azacitidine (A): 75 mg/m²/day subcutaneously or intravenously on days 1-7. * Treatment Cycle:Each regimen is administered for two cycles with a 3-week interval between cycles, followed by maintenance therapy. 2. Maintenance Therapy After Two Consolidation Cycles * Pegylated Interferon α-2b (Long-acting Interferon): 180μg subcutaneously every two weeks. Continued until disease progression or unacceptable toxicity occurs. | Other | Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel |
Primary outcome
Disease-Free Survival (DFS)
Time frame: 24 months
The Complete Response (CR) rate
Time frame: 24 months
The Complete Response (CR) rate refers to the proportion of patients achieving complete remission in a treatment regimen.
Partial Response (PR) rate
Time frame: 24 months
The Partial Response (PR) rate in oncology indicates the proportion of patients experiencing a significant reduction in tumor size post-treatment.
No Remission (NR)
Time frame: 24 months
Non-Response (NR) in medicine refers to the lack of therapeutic response, indicating no significant improvement in a patient's condition post-treatment.
CR with incomplete hematologic recovery (CRi)
Time frame: 24 months
Therapeutic efficacy
Time frame: 24 months
The efficacy of the preparative regimen and anti-GVHD regimen for allogeneic stem cell transplantation in AML patients.
5 secondary outcomes
Treatment-Related Mortality (TRM)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Event-Free Survival (EFS)
Time frame: 24 months
Therapeutic efficacy
Time frame: 24 months
Adverse Event
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML, First Induction (IAV or DAV Regimen) and Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen in people with Acute Myeloid Leukemia, run by Shanxi Bethune Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Wang, Dr. (13835175119, wangtao99699@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.