Ruxolitinib and Decitabine for High Risk Hematological Malignancies

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Decitabine intensified Conditioning Regimen in Patients with High Risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Decitabine

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);