Clinical trial NCT05088226: Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen
Official title: Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen for Patients With Acute B Cell Lymphoblast Leukemia Underwenting Haploidenticl Peripheral Blood Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral Blood Stem Cell Transplantation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria
timeFrame: 365 days after transplantation
Secondary outcomes:
measure: DFS(disease-free survival )
timeFrame: 365 days after transplantation
measure: TRM(treatment-related mortality )
timeFrame: 365 days after transplantation
measure: Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)
timeFrame: 365 days after transplantation
measure: Proportion of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)
timeFrame: 365 days after transplantation
measure: OS(overall survival )
timeFrame: 365 days after transplantation
measure: Failure-free survival (FFS)
timeFrame: 365 days after transplantation
measure: infection rate
timeFrame: 365 days after transplantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Daihong Liu
role: PRINCIPAL_INVESTIGATOR
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