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

NCT07108530 | Recruiting Phase 2

• 1 other identifier: ShanxiBethuneH2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (6)

• Disease-Free Survival (DFS)

  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.

  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.

  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.

  24 months

• CR with incomplete hematologic recovery (CRi)

  24 months

• Therapeutic efficacy

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

  24 months

Secondary Outcomes (5)

• Treatment-Related Mortality (TRM)

  24 months

• Overall Survival (OS)

  24 months

• Event-Free Survival (EFS)

  24 months

• Therapeutic efficacy

  24 months

• Adverse Event

  24 months

Study Arms (1)

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

Interventions

Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML OTHER

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.

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

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）

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

Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen DRUG

* 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).

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

Subsequent Treatment Plan for Transplant-Eligible Patients OTHER

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.

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

Allogeneic Stem Cell Transplantation Protocol OTHER

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

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

GVHD Prophylaxis Regimen OTHER

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.

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

Subsequent Consolidation Therapy for Transplant-Ineligible Patients OTHER

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.

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

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of intracranial hemorrhage;
• Pregnancy;
• Psychiatric illness or other conditions precluding protocol adherence;
• Severe cardiac arrhythmia, abnormal ECG (QTc \>500 ms).

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

DAV regimen

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Tao Wang, Dr.

CONTACT

13835175119; wangtao99699@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 7, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): August 6, 2027
• Study Completion (Estimated): August 6, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-06

Locations

CN (1)