Status:
UNKNOWN
Efficacy and Safety of Lenalidomide Combined With Azacitidine vs Azacitidine in the Treatment of MDS-RS
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
At present, the main therapies for myelodysplastic syndromes with ring sideroblasts (MDS-RS) are red blood cell and platelet transfusion, erythropoietin (EPO), androgen, and iron chelation therapy. Le...
Detailed Description
Myelodysplastic neoplasms (MDS) are heterogeneous clonal disorders of stem cells that result in peripheral blood cytopenia and ineffective hematopoiesis, with the potential risk of the development of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06004765
Start Date
August 1 2023
End Date
August 1 2025
Last Update
August 22 2023
Active Locations (1)
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1
Peking union medical college hospital
Beijing, China