Using Ruxolitinib and Chidamide for treating Acute T Cell Lymphoblast Leukemia
Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen for Patients With Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma Underwenting Haploidenticl Peripheral Blood Stem Cell Transplantation
This study is testing a new treatment using Ruxolitinib and Chidamide to see if it can help patients with Acute T Cell Lymphoblast Leukemia have better outcomes after a stem cell transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| 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) |
| Trial ID | NCT05075681 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of a modified conditioning regimen using Ruxolitinib and Chidamide for patients with Acute T Cell Lymphoblast Leukemia or Lymphoblastic Lymphoma undergoing haploidentical peripheral blood stem cell transplantation. The regimen is designed to enhance the outcomes of transplantation by intensifying the traditional Bu/Cy conditioning approach. Eligible patients will be monitored for their response to this intensified treatment and overall transplant success.
Who should consider this trial
Good fit: Ideal candidates are patients aged 12 to 65 with high-risk Acute T Cell Lymphoblast Leukemia who have haploidentical donors.
Not a fit: Patients who are pregnant or have severe mental illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with high-risk Acute T Cell Lymphoblast Leukemia.
How similar studies have performed: While this approach is novel, similar studies have shown promise in enhancing transplant outcomes for hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. high risk Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma with the indications for allogeneic transplantation; 2. Have 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;
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.