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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanxi Bethune Hospital
  Taiyuan, Shanxi, China Recruiting

Study contacts

• Study coordinator: Tao Wang, Dr.
• Email: wangtao99699@163.com
• Phone: 13835175119

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.