Using TBI and BUMEL for Stem Cell Transplant in AML Patients

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 study investigates the effectiveness and safety of a conditioning regimen combining total body irradiation (TBI) and BUMEL for patients with relapsed or refractory acute myeloid leukemia (AML) undergoing salvage allogeneic hematopoietic stem cell transplantation (HSCT). The study aims to evaluate the factors influencing efficacy and the occurrence of adverse events associated with this treatment approach. Patients aged 14 to 70 diagnosed with R/R AML will be included, and their outcomes will be monitored to assess the potential benefits of this regimen compared to traditional methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 14 and 70 years (inclusive of the age limits);
2. Patients diagnosed with relapsed/refractory (R/R) AML, meeting the World Health Organization (WHO) 2016 AML diagnostic criteria, must meet one of the following definitions:

   Relapsed AML: Leukemic cells reappear in peripheral blood or bone marrow blasts \>5% after achieving complete remission (CR, CRi) (excluding other causes such as bone marrow regeneration following consolidation chemotherapy), or extramedullary leukemic infiltration occurs.

   Refractory AML:Initial cases that do not respond to two courses of standard treatment. Relapse within 12 months after consolidation therapy. Relapse after 12 months with no response to conventional chemotherapy. Two or more relapses. Persistent extramedullary leukemia.
3. Heart, liver, and kidney function must meet the following criteria:

   Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3× the upper limit of normal (ULN); Total bilirubin ≤ 3× ULN; Serum creatinine ≤ 2× ULN or creatinine clearance ≥ 40 mL/min; Left ventricular ejection fraction (LVEF), as measured by echocardiography or multi-gated acquisition (MUGA) scan, must be within the normal range (\>50%).
4. Availability of a suitable allogeneic donor;
5. Life expectancy of ≥3 months;
6. Karnofsky Performance Status (KPS) ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
7. The patient understands the study protocol and voluntarily signs the informed consent form.

Exclusion Criteria:

1. Patients had serious adverse reactions to investigational drugs such as allergies;
2. Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation;
3. Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or other grade III or higher cardiovascular events within 6 months;
4. Patients received Class II or higher surgery within 4 weeks prior to enrollment;
5. Patient has an active and difficult-to-control infection, including but not limited to active fungal, bacterial, or viral infections that require systemic treatment, such as active HIV, hepatitis B or C;
6. Patient has active central nervous system leukemia infiltration;
7. Pregnant or lactating patients;
8. Patient is currently participating in another clinical studies;
9. Other conditions where the investigator deems the patient unsuitable for inclusion.

Where it's running

• Hematology Department, The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiaojin Wu, Prof.
• Email: wuxiaojin@suda.edu.cn
• Phone: 13057493105

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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.