A Single-Arm, Prospective Study of TBI+BUMEL as Conditioning for SCT2 in Patients With Malignant Hematologic Diseases

The primary challenges of SCT2 include:

• treatment strategy: eliminating residual tumor cells and addressing graft failure;
• immune regulation: adjusting the immune system to ensure successful engraftment of new stem cells;
• complication management: due to the poor physical condition of patients after the first transplant (SCT1), the risk of complications after SCT2 is high. This necessitates special attention to the prevention and management of post-transplant complications;
• transplantation technique improvements: more rigorous donor screening, HLA typing, monitoring, and supportive treatment during the transplant procedure.

Inclusion criteria

• Gender is not limited, patients between 14 to 70 years old (including critical value);
• Malignant hematological diseases (acute/chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, malignant lymphoma, etc.) diagnosed by bone marrow aspiration or biopsy according to the WHO diagnostic criteria, after the first hematopoietic stem cell transplantation, due to various reasons (including but not limited to disease relapse or graft failure) have indications for a second hematopoietic stem cell transplantation;
• The indexes of cardiac function, liver and kidney function were within the following limits: (1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× Upper limit of normal (ULN); (2)Total bilirubin ≤ 3×ULN; (3) Serum creatinine ≤ 2×ULN or creatinine clearance ≥ 40mL/min; (4) Left ventricular ejection fraction (LVEF) as measured by echocardiography or multi-gated acquisition (MUGA) scan is within the normal range (> 50%);
• Having a suitable allogeneic hematopoietic stem cell donor;
• Expected survival ≥3 months;
• Karnofsky (KPS) score ≥60%, Eastern Tumor Cooperative group (ECOG) status ≤ 2;
• Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.

Exclusion criteria

• Patients had serious adverse reactions to investigational drugs such as allergies;
• Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation;
• 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;
• Received Class II or higher surgery within 4 weeks prior to enrollment;
• Patients with active viral infections;
• Pregnant or lactating patients;
• The patient is currently participating in another clinical studies;
• Patients deemed unsuitable for inclusion by other investigators.