Ruxolitinib and chidamide–intensified busulfan/cyclophosphamide conditioning for peripheral blood stem cell transplant

Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen for Patients With Acute B Cell Lymphoblast Leukemia Underwenting Haploidenticl Peripheral Blood Stem Cell Transplantation

This trial tests whether adding ruxolitinib and chidamide to a busulfan/cyclophosphamide conditioning regimen helps people aged 12–65 with high‑risk B‑cell acute lymphoblastic leukemia who are receiving allogeneic peripheral blood stem cell transplants.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 12 Years to 65 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Drugs / interventions: Ruxolitinib
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05088226 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study tests a modified Bu/Cy conditioning regimen intensified with ruxolitinib and chidamide in patients with high‑risk B‑cell acute lymphoblastic leukemia undergoing allogeneic peripheral blood stem cell transplantation, including haploidentical donors. The single‑center trial at Chinese PLA General Hospital will enroll patients aged 12–65 with adequate organ function and ECOG performance status ≤2. Participants receive the intensified conditioning before transplant and are followed for safety, engraftment, graft‑versus‑host disease, relapse, and survival outcomes. The protocol excludes Ph‑positive ALL, pregnant patients, and those with uncontrolled infections or severe mental illness.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12–65 with high‑risk B‑cell acute lymphoblastic leukemia who are eligible for allogeneic peripheral blood stem cell transplantation (matched sibling, ≥8/10 matched unrelated, or haploidentical donors) and who have adequate liver and kidney function and ECOG ≤2.

Not a fit: Patients with Philadelphia chromosome–positive ALL, uncontrolled infections, significant organ dysfunction, pregnancy, or inability to comply with the protocol are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, the regimen could lower relapse risk and improve survival after allogeneic peripheral blood stem cell transplantation for high‑risk B‑cell ALL.

How similar studies have performed: Single‑agent or single‑class use of ruxolitinib or HDAC inhibitors around transplant has shown some promise in limited studies, but combining ruxolitinib and chidamide with Bu/Cy conditioning is a novel approach with limited prior evidence.

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;

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Daihong Liu — Chinese PLA General Hospital
• Study coordinator: Daihong Liu

Conditions Peripheral Blood Stem Cell Transplantation