Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen

NCT05088226 · tracked via the Priya Life Science China tracker

Sponsor

Chinese PLA General Hospital

Phase

Phase 2

Started

2021-12-01

Last updated

2026-04-23

Condition(s) studied

Peripheral Blood Stem Cell Transplantation

Investigational drug(s) / intervention(s)

Ruxolitinib combined with Chidamide.All Ruxolitinib trials (45) →All Chidamide trials (33) →

Ruxolitinib 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;

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

65 Years

Healthy volunteers

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 outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Chinese PLA General Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05088226 on ClinicalTrials.gov ↗ ← All trials in China