Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study

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• Leukemia, Myeloid, Acute 2,971

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 744 are open to participants now.

This study's planned enrollment of 50 is above the median of 41 across 2,508 interventional studies indexed under Leukemia, Myeloid, Acute.

Lead sponsor

Shanxi Bethune Hospital is the lead sponsor of 21 studies on the registry; 20 are open to participants now.

Study arms

• Experimental
  Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel

  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

Interventions

• OtherIntegrated 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.

• DrugFirst 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）

• DrugConsolidation 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).

• OtherSubsequent 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.

• OtherAllogeneic 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

• OtherGVHD 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.

• OtherSubsequent 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.

Primary outcomes

1. Disease-Free Survival (DFS)

   Time frame: 24 months

2. The Complete Response (CR) rate

   The Complete Response (CR) rate refers to the proportion of patients achieving complete remission in a treatment regimen.

   Time frame: 24 months

3. 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.

   Time frame: 24 months

4. 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.

   Time frame: 24 months

5. CR with incomplete hematologic recovery (CRi)

   Time frame: 24 months

6. Therapeutic efficacy

   The efficacy of the preparative regimen and anti-GVHD regimen for allogeneic stem cell transplantation in AML patients.

   Time frame: 24 months

Secondary outcomes

1. Treatment-Related Mortality (TRM)

   Time frame: 24 months

2. Overall Survival (OS)

   Time frame: 24 months

3. Event-Free Survival (EFS)

   Time frame: 24 months

4. 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.

   Time frame: 24 months

5. Adverse Event

   Time frame: 24 months