Updated May 2026 · ClinicalTrials.gov
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
Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study (NCT07108530) is a Phase 2 interventional studying Acute Myeloid Leukemia, sponsored by Shanxi Bethune Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.
About This Trial
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.
What Stage of Research Is This?
Phase 2 trials evaluate whether a treatment actually works against Acute Myeloid Leukemia and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.
This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.
Target enrollment of 50 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Acute Myeloid Leukemia subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.
Who May Be Eligible (Plain English)
These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML
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)
* 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 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).
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: 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.
Allogeneic Stem Cell Transplantation Protocol
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 Regimen
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 Patients
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. 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.
Locations (1)
Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.
How to Talk to Your Doctor About This Trial
Bring the printable summary of this trial — including the NCT ID (NCT07108530), the sponsor (Shanxi Bethune Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.
Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.
Authoritative Sources
The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.
Frequently Asked Questions
What is the NCT07108530 clinical trial studying?
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 (… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.
Who can participate in NCT07108530?
Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.
How do I contact the trial site for NCT07108530?
Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.
Is participating in a clinical trial safe?
Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.
Where can I verify the data on this page?
Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.
How This Page Is Built
Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.
Source: ClinicalTrials.gov API v2 record for NCT07108530. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07108530. Data: ClinicalTrials.gov."
Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
Last updated 2026-05-08 · Data from ClinicalTrials.gov.