Myeloid Malignancies
Conditions
Keywords
myeloid malignancies, allo-HSCT
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.
Interventions
DRUGfractionated busulfan-based conditioning regimen
Drug: Chidamide 30 mg oral twice weekly for 2 weeks Drug: Fludarabine 35 mg/m2 intravenously daily for 5 days in the 2nd week Drug: Cytarabine 1 g/m2 intravenously for 5 days in the 2nd week Drug: Busulfan 3.2 mg/kg intravenously daily for 2 days in the 1st week, 1.6 mg/kg intravenously daily for 4 days in the 2nd week Procedure/Surgery: allogeneic hematopoietic stem cell transplantation
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF); 2. KPS score \> 60 or ECOG score 0-2; 3. The expected survival period \> 3 months; 4. 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%. 5. Those who have no central nervous system involvement or serious functional damage to important organs of the body; 6. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
Exclusion criteria
1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.; 2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective; 3. 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; 4. Combined with other malignant tumors and require treatment; 5. Pregnant or lactating females; 6. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome; 7. Patients with active chronic hepatitis B or active hepatitis C; 8. History of prolonged QT syndrome; 9. Patients considered by other researchers to be unsuitable for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 2 years | Overall survival of this group of patients at the end of 2 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
China
Outcome results
None listed