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)
Completed
- Conditions
- Leukemia, Myelomonocytic, ChronicMyelodysplastic SyndromesLeukemia, Myeloid, Acute
- Registration Number
- NCT05218902
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Serious Adverse Events (SAEs) Up to 12 Months Incidence of Adverse Drug Reactions (ADRs) Up to 12 Months Incidence of Adverse Events (AEs) Up to 12 Months
- Secondary Outcome Measures
Name Time Method Best Overall response rate (ORR) defined as the proportion of participants who achieved best response of superior to stable disease Up to 12 Months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of Azacitidine improve outcomes in IPSS high-risk MDS and CMML patients in China?
How does Azacitidine compare to hypomethylating agents in treating AML with 20-30% blasts and dysplasia?
Which biomarkers predict response to Azacitidine in IPSS intermediate-2 MDS patients under China's guidelines?
What are the common adverse events of Azacitidine in Chinese AML patients with multi-lineage dysplasia and how are they managed?
Are there combination therapies with Azacitidine showing improved efficacy in high-risk MDS compared to monotherapy?
Trial Locations
- Locations (1)
Local Institution - 0001
🇨🇳Tianjin, Tianjin, China