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Trial Title:
Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML
NCT ID:
NCT06385808
Condition:
Relapse Leukemia
Refractory Acute Myeloid Leukemia
Conditioning
Hematopoietic Stem Cell Transplantation
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Fludarabine
Busulfan
Mitoxantrone
Thiotepa
Conditions: Keywords:
relapsed or refractory acute myeloid leukemia
conditioning regimen
allogeneic hematopoietic stem cell transplantation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF
regimen prior to salvageable allogeneic hematopoietic stem cells. The one-year
recurrence-free survival after transplantation of these patients and the safty of the
MTBF regimen will be studied.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MTBF regimen
Description:
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.
Arm group label:
MTBF regimen group
Other name:
Mitoxantrone Hydrochloride Liposome
Other name:
Thiotepa
Other name:
Busulfan
Other name:
Fludarabine
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.
Detailed description:
High-intensity conditioning regimen prior to allogeneic hematopoietic stem cell
transplantation (allo-HSCT) can maximize the clearance of leukemia cells, but is often
associated with increased pretreatment-related toxicity and transplant-related mortality.
In order to enhance its anti-tumor effect without increasing or even decreasing its
tissue toxicity, and then prolong the overall survival of AML patients, we optimized the
conditioning regimen before allo-HSCT transplantation: (1) The classical
Thiotepa/Busulfan/Fludarabine (TBF) regimen will be adopted to reduce the conditioning
associated toxicity, ensure graft implantation to the maximum extent and reduce the
recurrence rate; ② At the same time, mitoxantrone hydrochloride liposome will be added to
avoid the disadvantages of weak immunosuppressive effect and weak anti-leukemia effect,
and MTBF pretreatment scheme will be finally explored. It has been applied in the
pre-treatment of salvage allo-HSCT in 3 patients with relapsed and refractory acute
myeloid leukemia with good safety. Up to the present follow-up time of 4 months, all 3
patients have disease free survival. To evaluate the safety and efficacy of this
protocol, we intend to include more patients undergoing salvage allo-HSCT for relapsed or
refractory (R/R) AML.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Source:
First Affiliated Hospital Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06385808
