Combining Umbilical Cord Blood Transplantation with Reduced-Toxicity Conditioning for High-Risk Blood Cancers
Total Body Irradiation/ Fludarabine/ Busulfan/ Cyclophosphamide (TFBC) Combined With Umbilical Cord Blood Transplantation (UCBT) in the Treatment of High-risk Malignant Hematological Diseases
This study is testing a new way to treat high-risk blood cancers like leukemia by using a gentler conditioning process before patients receive umbilical cord blood transplants to see if it helps them recover better.
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 | Chemotherapy, immunotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT05929092 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a reduced-toxicity myeloablative conditioning regimen combined with umbilical cord blood transplantation (UCBT) in treating patients with high-risk malignant hematological diseases such as leukemia and multiple myeloma. The approach aims to improve patient outcomes by enhancing neutrophil engraftment and reducing treatment-related complications. Patients will undergo a conditioning regimen that includes busulfan, cyclophosphamide, and fludarabine before receiving UCBT. The study will evaluate the safety and efficacy of this combined treatment in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 to 70 with high-risk malignant hematological diseases who meet specific health criteria.
Not a fit: Patients with low-risk hematological diseases or those who do not meet the health criteria for the study may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with high-risk malignant hematological diseases.
How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly in improving engraftment and survival rates in patients undergoing umbilical cord blood transplantation.
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. High-risk malignant hematological diseases (acute lymphoblastic leukemia, acute/chronic myeloid leukemia, multiple myeloma, etc.) diagnosed by bone marrow aspiration or biopsy according to the WHO diagnostic criteria; 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. Umbilical cord blood with HLA match ≥ 4/6; 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. Two or more surgeries were performed within 4 weeks prior to enrollment; 5. Patients with active viral infections, including HIV, HBV, HCV, TP; 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
- The First Affiliated Hospital of Soochow university — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Xiaojin Wu
- Email: wuxiaojin@suda.edu.cn
- Phone: +8613057493105
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.