NCT06879847 A Single-arm, Prospective Study of TBI + BUMEL As a Conditioning Regimen for Salvage HSCT in Patients with R/R AML
| NCT ID | NCT06879847 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Relapsed or Refractory Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-12-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Acute myeloid leukemia (AML) is one of the hematologic malignancies, for which patients typically undergo chemotherapy to achieve complete remission. However, approximately 30% of patients fail to respond to initial treatment, and many experience relapse after achieving remission. For patients with relapsed or refractory AML, allogeneic hematopoietic stem cell transplantation (HSCT) offers a potentially curative option. Sibling-matched HSCT has demonstrated a disease-free survival rate of 20-30%, while unrelated donor transplants yield an overall survival rate of approximately 22%. Haploidentical transplantation is a viable alternative for patients lacking a sibling donor. A 2019 study involving 1,693 patients with relapsed/refractory (R/R) AML revealed that haploidentical transplants yielded outcomes comparable to other transplant modalities, including HLA-matched and 9/10 matched unrelated donor transplants, thus supporting haploidentical transplantation as a viable therapeutic option. The conditioning regimen is a critical component of the transplantation. In China, the modified BU/CY conditioning regimen, which combines busulfan (BU) and cyclophosphamide (CTX), is widely utilized for tumor cytoreduction and immunosuppression. Some centers also employ post-transplant cyclophosphamide (PTCy) to mitigate the risk of graft-versus-host disease (GVHD). Despite advances, relapse remains a significant challenge. Optimizing conditioning regimens to enhance tumor cell targeting and achieve deeper remission is crucial. Additionally, many patients are unfit due to prior chemotherapy, infections, and organ dysfunction, which may make them unable to tolerate high-intensity conditioning. Recent studies suggest that melphalan (MEL)-based conditioning regimens may offer advantages over CTX-based protocols. While total body irradiation (TBI) has been traditionally used in conditioning for HSCT, it is associated with considerable organ toxicity. A low-dose TBI regimen combined with BU+MEL represents a promising conditioning regimen for R/R AML. In preliminary studies, 7 patients treated with this regimen successfully achieved hematopoietic stem cell engraftment. Building on these results, a clinical study is planned to evaluate further the safety and efficacy of the TBI+BUMEL (IBM) conditioning regimen in relapsed/refractory AML, with a focus on improving engraftment rates, reducing relapse rates, minimizing GVHD incidence, and enhancing overall survival outcomes.
Eligibility 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.
Contact & Investigator
Depei Wu, Prof.
STUDY CHAIR
The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT06879847 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 70 Years, studying Relapsed or Refractory Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06879847 currently recruiting?
Yes, NCT06879847 is actively recruiting participants. Contact the research team at wuxiaojin@suda.edu.cn for enrollment information.
Where is the NCT06879847 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT06879847 clinical trial?
NCT06879847 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Depei Wu, Prof. at The First Affiliated Hospital of Soochow University. The trial plans to enroll 40 participants.
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