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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Daihong Liu — Chinese PLA General Hospital
• Study coordinator: Daihong Liu
• Email: daihongrm@163.com
• Phone: 86-13681171597

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Graft-versus-host disease after stem cell transplant: testing LBP-MARCO with ruxolitinib

  We are testing whether combining LBP-MARCO with ruxolitinib is safe for adults with GVHD after a stem cell transplant.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07913672

• DMR-001 in CALR-mutant myeloproliferative neoplasms

  This study tests DMR-001 alone for CALR-mutant essential thrombocythemia or myelofibrosis, and in combination with ruxolitinib for CALR-mutant myelofibrosis.

  Recruiting at 3 sites Phase 1 Damora Therapeutics · Birmingham, Alabama and 35 other locations · NCT07849231

• Testing WJ01024 Alone and with Ruxolitinib for Myelofibrosis with Splenomegaly

  This early-phase study tests whether WJ01024, by itself or with ruxolitinib, is safe and tolerable and whether it shows signs of activity in adults with myelofibrosis and enlarged spleen.

  Recruiting Phase 1 Henan Cancer Hospital · Zhengzhou, Henan · NCT07802405

• Belumosudil vs. Ruxolitinib for hepatic cGVHD after HSCT

  This trial tests whether belumosudil or ruxolitinib works better for hepatic chronic GVHD after a stem cell transplant in people 12 and older.

  Recruiting First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07794514

• Topical ruxolitinib for adults with pyoderma gangrenosum

  This pilot study tests a topical cream of ruxolitinib to see if it helps heal PG ulcers in adults without adding systemic immunosuppressants.

  Recruiting Phase 2 Oregon Health and Science University · Portland, Oregon · NCT07783412

• Ruxolitinib Cream Plus Corticosteroids for Facial Non-Segmental Vitiligo in Real-World Practice

  This real-world study tests whether adding 1.5% ruxolitinib cream to corticosteroids helps people 12 and older with active facial non-segmental vitiligo.

  Recruiting at 6 sites Dermavon Holdings Limited · Shenzhen, Guangdong and 19 other locations · NCT07673640

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.