TBI/Flu/Bu/Mel Combined With Secondary UCBT in Patients With Hematological Malignancies Who Relapsed After Allo-HSCT

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Nov 6, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with certain blood cancers, like leukemia, who have experienced a relapse after receiving a prior stem cell transplant. The researchers are testing a specific preparation method, called TBI/Flu/Bu/Mel, which combines different medications and low-dose radiation to improve the success of a second umbilical cord blood transplant (UCBT). UCBT uses blood stem cells collected from umbilical cords, which can be a good option for patients who have trouble finding matching donors. The goal is to see if this new approach can help patients recover better and live longer after treatment.

To participate in the trial, individuals must be between 10 and 65 years old, have a confirmed diagnosis of blood cancer, and plan to receive a UCBT. Other health criteria, like heart and kidney function, must also be met. Participants will be closely monitored during the study to evaluate how well the treatment works and to check for any side effects. This trial aims to provide new hope for patients facing difficult relapses in their cancer journey.

Gender

ALL

Eligibility 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.