Efficacy and Safety of Lenalidomide Combined With Azacitidine vs Azacitidine in the Treatment of MDS-RS
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes
Eligibility Criteria
Inclusion Criteria: Age >18 years old. Patients with a definite diagnosis of MDS-RS and stratified as lower-risk according to IPSS-R. After at least 3 months of rhEPO treatment, with hemoglobin<90g/L, absolute neutrophil count≥1.0× 109 /L, and platelet≥30× 109 /L Unconditional hematopoietic stem cell transplantation Adequate hepatic functions with alanine transaminase (ALT)/aspartate. transaminase (AST) levels within 2 times of the normal upper limit and total bilirubin levels within 2 times of the normal upper limit. 5. No active infection; Not pregnant or breastfeeding 6. ECOG≦2 with an expected life span of more than 6 months 7. Documented patient consent. Exclusion Criteria: Proliferative (white blood cell count ≥12× 109 /L) chronic myelomonocytic leukemia. Complicated with active or uncontrolled infections. Complicated with other malignancies. Creatinine/transaminase ≥ 2 normal upper limit. Complicated with myelofibrosis.
Sites / Locations
- Peking union medical college hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
lenalidomide and sequential azacitidine
azacitidine
Lenalidomide (10mg/d *21 days, 28 days for 1 course), at least 2 courses. If effective, continue to use lenalidomide until ineffective or intolerant. Patients receive azacitidine (75mg/m2/d*5 days, 28 days for 1 course). Until progression or intolerance. At least 2 sessions of treatment are needed.
Azacitidine (75mg/m2/d*5 days, 28 days for 1 course) for at least 4 courses