Using Ruxolitinib and Decitabine for patients with high risk blood cancers undergoing stem cell transplantation
Ruxolitinib and Decitabine Intensified Conditioning Regimen for Patients With High Risk Hematological Malignancies Underwenting Allogeneic Stem Cell Transplantation
This study is testing a new treatment combining Ruxolitinib and Decitabine to see if it helps people with high-risk blood cancers have better outcomes after a stem cell transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | Ruxolitinib |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04582604 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of a modified conditioning regimen that combines Ruxolitinib and Decitabine for patients with high-risk hematological malignancies who are undergoing allogeneic peripheral blood stem cell transplantation. The investigators are testing this intensified regimen to improve transplant outcomes for patients with conditions such as relapsed or refractory acute leukemia and myelodysplastic syndromes. Eligible participants will receive the modified Bu/Cy conditioning regimen and will be monitored for efficacy and feasibility throughout the process.
Who should consider this trial
Good fit: Ideal candidates include patients aged 12 to 65 with high-risk hematological malignancies who are eligible for allogeneic stem cell transplantation.
Not a fit: Patients with uncontrolled infections, severe mental illness, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve transplant outcomes for patients with high-risk blood cancers.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving outcomes for patients undergoing stem cell transplantation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Relapsed/refractory acute leukemia with indications for allogeneic hematopoietic stem cell transplantation; High risk acute leukemia with indications for allogeneic hematopoietic stem cell transplantation; 2. Medium to high risk myelodysplastic syndrome, myeloproliferative disease, myelodysplastic syndrome/myeloproliferative disease, Chronic myelomonocytic leukemia; 3. Have matched sibling donors, ≥8/10 HLA matched unrelated donors or haploidentical donors 4. All patients should aged 12 to 65 years; 5. Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal; 6. Renal function: creatinine ≤the upper limit of normal; 7. Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2; 9. Have signed informed consent. Exclusion Criteria: 1. pregnant women; 2. Patients with mental illness or other states unable to comply with the protocol; 3. AML patients with t (15;17);
Where this trial is running
Beijing, Beijing
- Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Daihong Liu — Chinese PLA General Hospital
- Study coordinator: Daihong Liu
- Email: daihongrm@163.com
- Phone: 86-13681171597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.