NCT05218902
Completed
Not Applicable
A Prospective/Retrospective Non-Interventional Study of Vidaza® (Azacitidine) in Patients With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes, or Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia With 20-30% Blasts and Multi-lineage Dysplasia in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myelodysplastic Syndromes
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Incidence of Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 12 Months
Incidence of Adverse Drug Reactions (ADRs)
Time Frame: Up to 12 Months
Incidence of Adverse Events (AEs)
Time Frame: Up to 12 Months
Secondary Outcomes
- Best Overall response rate (ORR) defined as the proportion of participants who achieved best response of superior to stable disease(Up to 12 Months)
Study Sites (1)
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