Peripheral Blood Stem Cell Transplantation
Conditions
Brief summary
The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute B cell Lymphoblast leukemia Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.
Detailed description
Haploidenticl Peripheral blood Stem Cell Transplantation should be offered to eligible patients with Acute B cell Lymphoblast leukemia whenever feasible. To further improve the outcome of transplantation patients with Acute B cell Lymphoblast leukemia, we developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. In this study, we tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide in patients with Acute B cell Lymphoblast leukemia undergoing allogeneic peripheral blood stem cell transplantation.
Interventions
DRUGRuxolitinib combined with Chidamide.
Drug: modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide . Day -15 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -14 # Ruxolitinib 70mg bid; Day -13 # Ruxolitinib 70mg bid; Day -12 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -11 # Ruxolitinib 70mg bid; Day-10# Cytarabine 4g/m2/day CI , Ruxolitinib 60mg bid; Day- 9# Cytarabine 4g/m2/day CI, Ruxolitinib 60mg bid; Day- 8 # Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid, Chidamide 30 mg once; Day- 7# Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid; Day-6# Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 40mg bid; Day-5# Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 30mg bid, Chidamide 30 mg once; Day-4# Cyclophosphamide 1.8 g/m2/day CI,Ruxolitinib 20mg bid; Day-3# Carmustine 250mg/m2/ day iv, Ruxolitinib 10mg bid; Day-2# Ruxolitinib 5mg bid, Chidamide 30 mg/day; Day-1# Ruxolitinib 5mg qd;
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. high risk acute B cell lymphoblastic leukemia with the indications for allogeneic transplantation; 2. Have matched sibling donors, ≥8/10 HLA matched unrelated donors or haploidentical donors 3. All patients should aged 12 to 65 years; 4. Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal; 5. Renal function: creatinine ≤the upper limit of normal; 6. Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; 7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2; 8. Have signed informed consent.
Exclusion criteria
1. pregnant women; 2. Patients with mental illness or other states unable to comply with the protocol; 3. ALL patients with Ph positive;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria | 365 days after transplantation | Defined as the proportion of participants whose underlying malignancy relapsed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS(disease-free survival ) | 365 days after transplantation | DFS was defined as survival with no evidence of relapse or progression. |
| TRM(treatment-related mortality ) | 365 days after transplantation | Defined as the proportion of subjects who died due to causes other than malignancy relapse. |
| Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria) | 365 days after transplantation | Defined as the proportion of participants who developed acute GVHD. |
| Proportion of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria) | 365 days after transplantation | Defined as the proportion of participants who developed chronic GVHD. |
| OS(overall survival ) | 365 days after transplantation | OS was defined as the time from transplantation to death due to any cause. |
| Failure-free survival (FFS) | 365 days after transplantation | Defined as the time from tranplantation to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD). |
| infection rate | 365 days after transplantation | Defined as the proportion of participants who developed all kinds of infection. |
Countries
China
Contacts
CONTACTDaihong Liu
CONTACTLiping Dou
PRINCIPAL_INVESTIGATORDaihong Liu
Chinese PLA General Hospital
Outcome results
None listed