A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT U
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Bo
| Condition(s) | Acute Lymphoblastic Leukemia, Adult |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence |
| Who can participate | Inclusion Criteria: 1. Informed Consent: Participants must voluntarily sign a written informed consent form. 2. Age and Gender: Participants should be male or female, aged 18-65 years, inclusive. 3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to adults aged 18-65 years. 4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation. 5. Donor Availability: There must be a suitable mathced sibling donor available, and the participant must consent to undergo MSD hematopoietic stem cell transplantation (MSD-HSCT). 6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital of Zhengzhou University |
| Locations | Zhengzhou, Henan, China |
| Start date | 2025-03-01 |
| NCT ID | NCT06557161 |
| Official listing | https://clinicaltrials.gov/study/NCT06557161 |