Using TBI and BUMEL for Stem Cell Transplant in AML Patients
A Single-arm, Prospective Clinical Study on the Efficacy of Total Body Irradiation Combined with Busulfan and Melphalan As Conditioning Regimen for Patients with Relapsed/Refractory Acute Myeloid Leukemia Undergoing Salvage HSCT
This study is testing a new treatment plan using total body radiation and BUMEL to see if it helps young and middle-aged adults with tough cases of acute myeloid leukemia who need a stem cell transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06879847 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 to 70 with a diagnosis of relapsed or refractory acute myeloid leukemia.
Not a fit: Patients with other types of leukemia or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and treatment outcomes for patients with relapsed or refractory AML.
How similar studies have performed: Previous studies have shown promising outcomes with haploidentical transplants in similar patient populations, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Suzhou, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.