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Recruiting Phase 2 NCT05088226

Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen

Phase 2 – studying effectiveness and dosage
Conditions: Peripheral Blood Stem Cell Transplantation

Sponsor: Chinese PLA General Hospital

trial.available_in: БГ
Overview
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.
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.
Who can participate
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;
Interventions
Ruxolitinib combined with Chidamide.
DRUG
Locations 1
China (1)
Chinese PLA General Hospital
Beijing , Beijing Municipality
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
01.12.2021
Completion date
01.06.2031
Registry ID
NCT05088226
Source
clinicaltrials.gov
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