Status:
COMPLETED
A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Myelodysplastic Syndromes
Leukemia, Myelomonocytic, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.
Detailed Description
This study will have participants both enrolled retrospectively and prospectively for azacitidine (AZA) treatment.
Eligibility Criteria
Inclusion
- Documented diagnosis of intermediate-2/ high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) with 20-30% bone marrow blasts and multi-lineage dysplasia
- Initiated azacitidine (AZA) treatment per approved China Product Label after April 2017
Exclusion
- Contraindicated for the use of AZA according to China Product Label
- Simultaneously participating in a treatment intervention study
- Other protocol-defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
February 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT05218902
Start Date
February 25 2022
End Date
March 20 2023
Last Update
May 31 2023
Active Locations (1)
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1
Local Institution - 0001
Tianjin, Tianjin Municipality, China, 300010