Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission Myeloid Malignancies
- Conditions
- Myeloid Malignancies
- Interventions
- Drug: fractionated busulfan-based conditioning regimen
- Registration Number
- NCT05807659
- Lead Sponsor
- Sichuan University
- Brief Summary
The goal of this single-arm phase II study is to test in patients with non-remission myeloid malignancies undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer are:
* The safety and efficacy of fractionated busulfan Combined With Chidamide/Fludarabine/Cytarabine(ChiFAB) conditioning regimen in increasing the overall survival rate in patients with non-remission myeloid malignancies after allo-HSCT.
* The efficacy of fractionated busulfan conditioning regimen in reducing the recurrence rate in patients with non-remission myeloid malignancies after allo-HSCT.
Participants will receive fractionated busulfan-based ChiFAB conditioning regimen (busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6\~-3, fludarabine 35mg/m2 d-6\~-2, cytarabine 1g/m2,d-6\~-2, chidamide 30mg d-13,-10,-6,-3) before allo-HSCT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 18
- Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
- KPS score > 60 or ECOG score 0-2;
- The expected survival period > 3 months;
- Those who did not achieve complete remission after 2 or more chemotherapy regimens. The proportion of blasts on bone marrow smears before transplantation was ≥5%.
- Those who have no central nervous system involvement or serious functional damage to important organs of the body;
- Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
- Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
- Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
- Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
- Combined with other malignant tumors and require treatment;
- Pregnant or lactating females;
- Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
- Patients with active chronic hepatitis B or active hepatitis C;
- History of prolonged QT syndrome;
- Patients considered by other researchers to be unsuitable for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description fractionated busulfan fractionated busulfan-based conditioning regimen fractionated busulfan-based ChiFAB conditioning regimen: busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6\~-3, fludarabine 35mg/m2 d-6\~-2 cytarabine 1g/m2,d-6\~-2 chidamide 30mg d-13,-10,-6,-3
- Primary Outcome Measures
Name Time Method Overall survival (OS) 2 years Overall survival of this group of patients at the end of 2 year
- Secondary Outcome Measures
Name Time Method Cumulative incidence of acute graft versus host disease (aGVHD) Day +100 Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Cumulative incidence of chronic graft versus host disease (cGVHD) 2 years Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year
Non-relapse mortality (NRM) 6 months Non-relapse mortality of this group of patients at the end of 6 months
Relapse rate 2 years Relapse rate of this group of patients at the end of 2 year
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Chendu, Sichuan, China