Status:
RECRUITING
TBI/Flu/Bu/Mel Combined With Secondary UCBT in Patients With Hematological Malignancies Who Relapsed After Allo-HSCT
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Hematopoietic Malignancy
Relapse/Recurrence
Eligibility:
All Genders
10-65 years
Phase:
NA
Brief Summary
About 33% of patients with myeloid or lymphoid malignancies experience relapse with HLA loss after haplo-HSCT. Due to the specificity of HLA-loss relapse, the 2019 European Society for Blood and Marro...
Detailed Description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for hematological malignancies, and post-transplant relapse is the primary cause of death. The optimal treatmen...
Eligibility Criteria
Inclusion
- Gender is not limited, patients between 10 to 65 years old (including critical value);
- 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;
- Planned to received umbilical cord blood 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%);
- Umbilical cord blood with HLA match ≥ 6/10;
- 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;
- Patient was complicated with pulmonary infection, which was confirmed by imaging to be progressive;
- 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;
- Patients with active viral infections, including HIV, HBV, HCV, TP;
- 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 :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06125483
Start Date
November 1 2023
End Date
October 31 2026
Last Update
April 24 2025
Active Locations (1)
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1
The First Affiliated Hospital of Soochow university
Suzhou, Jiangsu, China