Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
pregnant women;
Patients with mental illness or other states unable to comply with the protocol;
ALL patients with Ph positive;
Trial design
Design model
Single group
Treatments tested in this trial
Ruxolitinib combined with Chidamide.
DrugDrug: 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;
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Ruxolitinib combined with ChidamideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria
Defined as the proportion of participants whose underlying malignancy relapsed.
Time frame
365 days after transplantationSecondary outcomes
1
DFS(disease-free survival )
DFS was defined as survival with no evidence of relapse or progression.
Time frame
365 days after transplantation2
TRM(treatment-related mortality )
Defined as the proportion of subjects who died due to causes other than malignancy relapse.
Time frame
365 days after transplantation3
Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)
Defined as the proportion of participants who developed acute GVHD.
Time frame
365 days after transplantation4
Proportion of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)
Defined as the proportion of participants who developed chronic GVHD.
Time frame
365 days after transplantationSponsors and contacts
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Source ClinicalTrials.gov