NCT05088226 Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen
| NCT ID | NCT05088226 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Peripheral Blood Stem Cell Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2030-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2021-12-01 with a primary completion date of 2030-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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;
Contact & Investigator
Daihong Liu
PRINCIPAL INVESTIGATOR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT05088226 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying Peripheral Blood Stem Cell Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05088226 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05088226 currently recruiting?
Yes, NCT05088226 is actively recruiting participants. Contact the research team at daihongrm@163.com for enrollment information.
Where is the NCT05088226 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05088226 clinical trial?
NCT05088226 is sponsored by Chinese PLA General Hospital. The principal investigator is Daihong Liu at Chinese PLA General Hospital. The trial plans to enroll 50 participants.