Combining decitabine with modified chemotherapy for high-risk acute leukemia before stem cell transplant
Decitabine Plus mBU/CY for High Risk Acute Leukemia With Minimal Residual Disease Pre-HSCT
This study is testing a new treatment combining decitabine and modified chemotherapy for people with high-risk acute leukemia to see if it helps them do better before getting a stem cell transplant.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT03793517 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of a combination treatment involving decitabine and modified busulfan/cyclophosphamide (mBU/CY) as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with high-risk acute leukemia who have detectable minimal residual disease (MRD) prior to transplantation. Patients will receive decitabine followed by a specific chemotherapy regimen tailored for both HLA-mismatched and matched sibling transplantations. The study aims to monitor the patients' bone marrow samples at various time points post-transplant to assess leukemia status and potential relapse. This approach seeks to improve outcomes for patients at high risk of leukemia relapse after transplantation.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with high-risk acute leukemia and detectable minimal residual disease prior to stem cell transplantation.
Not a fit: Patients who are pregnant or have uncontrolled severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of leukemia relapse in high-risk patients undergoing stem cell transplantation.
How similar studies have performed: Previous studies have shown that decitabine can be effective in treating recurrent or refractory leukemia, suggesting potential success for this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * acute leukemia patients with MLL-r,TLS-ERG,or SIL-TAL1,whose minimal residual disease were detectable pre-HSCT Exclusion Criteria: * pregnancy women * uncontrolled severe infection
Where this trial is running
Beijing, Beijing Municipality
- Peking University Institute of Hematology,Beijing — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiao-Jun Huang
- Email: yanchenhua@vip.sina.com
- Phone: +86 010 88326666
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.