Treatment for relapsed hematological malignancies using umbilical cord blood transplantation
A Clinical Study of Low-dose Total Body Irradiation and Fludarabine/Busulfan/Melphalan as a Conditioning Regimen for Secondary Umbilical Cord Blood Transplantation in Patients With Hematological Malignancies Who Relapsed After Allo-HSCT
This study is testing if umbilical cord blood transplantation can help patients with blood cancers who have relapsed after their first stem cell transplant and can't find a donor for a second one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 10 Years to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine, CAR-T, chimeric antigen receptor |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06125483 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of umbilical cord blood transplantation (UCBT) as a treatment for patients with hematological malignancies who have relapsed after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study focuses on patients experiencing HLA loss, which complicates their treatment options. By utilizing UCBT, the trial aims to provide an alternative source of hematopoietic stem cells for those who cannot find suitable donors for secondary transplantation. The approach is based on previous findings that suggest second transplantation can lead to prolonged disease-free survival compared to chemotherapy in similar patient populations.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 10 to 65 years who have been diagnosed with hematological malignancies and are experiencing relapse after allo-HSCT.
Not a fit: Patients who do not meet the age criteria or those with severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with relapsed hematological malignancies.
How similar studies have performed: Previous studies have shown that umbilical cord blood transplantation can be an effective treatment option for patients with hematological malignancies, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Gender is not limited, patients between 10 to 65 years old (including critical value); 2. According to the WHO diagnostic criteria, the diagnosis of hematological malignancies ( acute lymphoblastic leukemia, acute / chronic myeloid leukemia, etc. ) was confirmed by bone marrow puncture or biopsy after allogeneic hematopoietic stem cell transplantation. The definition of relapse includes the proportion of bone marrow blast cells \> 5 %, blast cells in peripheral blood ( excluding the use of G-CSF and GM-CSF ), or extramedullary leukemia infiltration; 3. Planned to received umbilical cord blood transplantation; 4. 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%); 5. Umbilical cord blood with HLA match ≥ 6/10; 6. Expected survival ≥3 months; 7. Karnofsky (KPS) score ≥60%, Eastern Tumor Cooperative group (ECOG) status ≤ 2; 8. 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. Patient was complicated with pulmonary infection, which was confirmed by imaging to be progressive; 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. Patients with active viral infections, including HIV, HBV, HCV, TP; 5. Pregnant or lactating patients; 6. The patient is currently participating in another clinical studies; 7. 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
- Principal investigator: Xiaojin Wu, Prof. — The First Affiliated Hospital of Soochow University
- Study coordinator: Xiaojin Wu, Prof.
- 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.