Integrated induction, consolidation, and transplant treatment for adult acute myeloid leukemia

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 program will try a combined chemotherapy-and-transplant approach that starts with one of two induction regimens (idarubicin- or daunorubicin-based with venetoclax), followed by consolidation and allogeneic stem cell transplant for adults with AML excluding M3.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: Shanxi Bethune Hospital (Academic / other)
• Drugs / interventions: methotrexate, Cyclophosphamide, Fludarabine
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT07108530 on ClinicalTrials.gov

What this trial studies

This is a multicenter, single-arm, open-label Phase 2 protocol that offers two induction options (IAV with idarubicin or DAV with daunorubicin, both combined with cytarabine and an 8-day venetoclax schedule) chosen in part by patients' financial resources. Consolidation is either a liposomal mitoxantrone plus intermediate-dose cytarabine (MA) or intermediate-dose cytarabine alone, after which patients who are MRD-negative and eligible proceed directly to allogeneic hematopoietic stem cell transplantation. The transplant uses a fludarabine plus busulfan/cyclophosphamide conditioning backbone with ATG and a GVHD prophylaxis strategy combining anti-CD25 monoclonal antibody and delayed oral cyclosporine. Safety, remission durability, and transplant outcomes including GVHD incidence will be followed as primary outcome domains.

Who should consider this trial

Good fit: Adults aged 14–65 with non‑M3 AML, ECOG 0–2, meeting Chinese adult AML diagnostic criteria and considered eligible for intensive chemotherapy and possible allogeneic transplant are the ideal candidates.

Not a fit: Patients with acute promyelocytic leukemia (M3), uncontrolled intracranial hemorrhage, pregnancy, severe cardiac arrhythmia or QTc >500 ms, or those unable to tolerate intensive therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this integrated approach could increase the rate of durable remissions and improve transplant outcomes for adult AML patients who can tolerate intensive therapy.

How similar studies have performed: Venetoclax combined with chemotherapy has shown promise in AML in other studies, but the specific integration with intensive anthracycline induction, MA consolidation and anti‑CD25 GVHD prophylaxis is relatively novel and less extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Where this trial is running

Taiyuan, Shanxi

• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Tao Wang, Dr.

Conditions Acute Myeloid Leukemia