Status:
RECRUITING
A Single-Arm, Prospective Study of TBI+BUMEL as Conditioning for SCT2 in Patients With Malignant Hematologic Diseases
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Malignant Hematological Diseases
Eligibility:
All Genders
14-70 years
Phase:
NA
Brief Summary
Each year, over 20,000 patients in China undergo hematopoietic stem cell transplantation (HSCT). Unfortunately, the prognosis in patients with disease relapse or graft failure is often inferior. A sec...
Detailed Description
The primary challenges of SCT2 include: 1. treatment strategy: eliminating residual tumor cells and addressing graft failure; 2. immune regulation: adjusting the immune system to ensure successful en...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06548958
Start Date
July 10 2024
End Date
June 30 2027
Last Update
March 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hematology Department, The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006