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NCT06385808

Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML

Sponsor: First Affiliated Hospital Xi'an Jiaotong University

View on ClinicalTrials.gov

Summary

The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients.

Official title: Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Combined With Thiotepa, Busulfan and Fludarabine Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed or Refractory Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-05-01

Completion Date

2026-12-31

Last Updated

2024-04-26

Healthy Volunteers

Conditions

Relapse Leukemia Refractory Acute Myeloid Leukemia Conditioning Hematopoietic Stem Cell Transplantation

Interventions

DRUG

MTBF regimen

The subjects will be treated with mitoxantrone hydrochloride liposome combined with thiotepa, busulfan and fludarabine as conditioning regimen prior to allo-HSCT. Mitoxantrone hydrochloride liposome 24mg/m\^2 ivgtt d-7; Ctepide 5mg/kg ivgtt d-6\~-5; Busulfan 0.8mg/kg q6h ivgtt d-4\~-2; Fludarabine 50mg/m\^2 ivgtt d-4\~-2.

Inclusion Criteria: * The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up; * Age 18-65 years old (including upper and lower limits); * No gender limitation * Relapsed or refractory (R/R) acute myeloid leukemia can not achieve complete remission by chemotherapy, and has the indication of salvage allogeneic hematopoietic stem cell transplantation. * R/R AML was defined as: ① Initial treatment cases that failed after 2 courses of standard chemotherapy; ② After CR consolidation and intensive treatment, relapse within 12 months; ③ Recurred 12 months later, but conventional chemotherapy was ineffective; ④ Two or more relapses; ⑤ Extramedullary leukemia persists; ⑥Leukemia cells in peripheral blood or the proportion of bone marrow original cells \>0.050 or the occurrence of extramedullary leukemia cell infiltration after CR. * Could tolerate allogeneic hematopoietic stem cell transplantation. Exclusion Criteria: * Hypersensitivity to any investigational drug or its components; * Uncontrolled systemic diseases (e.g. active infections, uncontrolled hypertension, diabetes, etc.) * Cardiac function and disease meet one of the following conditions: 1. Long QTc syndrome or QTc interval\>480 ms; 2. Complete left bundle branch block, II or III degree atrioventricular block; 3. Serious and uncontrolled arrhythmia requiring drug treatment; 4. American New York Heart Association rating ≥ III degree; 5. Cardiac ejection fraction (LVEF) is less than 60%; 6. History of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or He has any arrhythmia requiring treatment, clinical history of serious pericardial disease, or acute ischemia or activity ECG evidence of abnormal conduction system; * Active infection of hepatitis B and hepatitis C; * Human immunodeficiency virus (HIV) infection; * Patients with other malignant tumors; * History of drug abuse (non-medical use of narcotic drugs or psychotropic drugs) or history of drug dependence (sedative hypnotics, analgesics, narcotics, stimulants and psychotropic drugs, etc.); * History of mental illness or cognitive impairment; * Other investigators determined that participation in this study was not appropriate.