Using TBI and Melphalan for Second Stem Cell Transplantation in Blood Cancer Patients
A Single-Arm, Prospective Clinical Study of Total Body Irradiation Combined With Busulfan and Melphalan (TBI+BUMEL) as a Conditioning Regimen for Second Hematopoietic Stem Cell Transplantation in Patients With Malignant Hematologic Diseases
This study is testing if using total body radiation and a drug called melphalan can help blood cancer patients who need a second stem cell transplant after their first one didn't work.
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 | cyclophosphamide |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06548958 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of total body irradiation (TBI) combined with melphalan as a conditioning regimen for patients with malignant hematological diseases undergoing a second allogeneic hematopoietic stem cell transplantation (SCT2). The focus is on optimizing treatment strategies, immune regulation, complication management, and transplantation techniques to improve outcomes for patients who have experienced relapse or graft failure after their first transplant. By addressing these challenges, the study aims to enhance the overall survival rates and quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 to 70 with malignant hematological diseases who have indications for a second stem cell transplantation due to relapse or graft failure after the first transplant.
Not a fit: Patients who are not eligible for a second stem cell transplantation or those with severe comorbidities that preclude them from undergoing the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and treatment outcomes for patients with malignant hematological diseases undergoing a second stem cell transplant.
How similar studies have performed: While SCT2 is a recognized salvage therapy, this specific combination of TBI and melphalan is being explored for its potential benefits, indicating a novel approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Gender is not limited, patients between 14 to 70 years old (including critical value); 2. 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; 3. 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%); 4. Having a suitable allogeneic hematopoietic stem cell donor; 5. Expected survival ≥3 months; 6. Karnofsky (KPS) score ≥60%, Eastern Tumor Cooperative group (ECOG) status ≤ 2; 7. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent. 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. Received Class II or higher surgery within 4 weeks prior to enrollment; 5. Patients with active viral infections; 6. Pregnant or lactating patients; 7. The patient is currently participating in another clinical studies; 8. Patients deemed unsuitable for inclusion by other investigators.
Where this trial is running
Suzhou, Jiangsu
- Hematology Department, The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Depei Wu, Prof. — The First Affiliated Hospital of Soochow University
- 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.