Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen for Patients With Acute B Cell Lymphoblast Leukemia Underwenting Haploidenticl Peripheral Blood Stem Cell Transplantation
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •high risk acute B cell lymphoblastic leukemia with the indications for allogeneic transplantation;
- •Have matched sibling donors, ≥8/10 HLA matched unrelated donors or haploidentical donors
- •All patients should aged 12 to 65 years;
- •Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal;
- •Renal function: creatinine ≤the upper limit of normal;
- •Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- •Have signed informed consent.
Exclusion Criteria
- •pregnant women;
- •Patients with mental illness or other states unable to comply with the protocol;
- •ALL patients with Ph positive;
Arms & Interventions
Ruxolitinib combined with Chidamide
Experimental: Ruxolitinib combined with Chidamide. All recipients in this arm received the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. The conditioning regimen for allogeneic hematopoietic stem cell transplantation consist of ruxolitinib (35 mg bid [p.o.], days -15 to -10, diminishing to day -1), chidamide (30 mg/day, twice per week from days -15 to -2), cytarabine (4g/m2/day, days -10 to -9), busulfan (0.8mg/kg, Q6h, days -8 to -6), cyclophosphamide (1.8 g/m2/day, days -5 to -4), carmustine(BCNU) (250mg/m2/day, day -3)
Intervention: Ruxolitinib combined with Chidamide. (Drug)
Outcomes
Primary Outcomes
Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria
Time Frame: 365 days after transplantation
Defined as the proportion of participants whose underlying malignancy relapsed.
Secondary Outcomes
- Failure-free survival (FFS)(365 days after transplantation)
- TRM(treatment-related mortality )(365 days after transplantation)
- Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)(365 days after transplantation)
- OS(overall survival )(365 days after transplantation)
- infection rate(365 days after transplantation)
- DFS(disease-free survival )(365 days after transplantation)
- Proportion of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)(365 days after transplantation)
Investigators
Daihong Liu
Director
Chinese PLA General Hospital