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)
DIM Vidaza
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
1 other identifier
observational
290
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
February 1, 2022
CompletedStudy Start
First participant enrolled
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2023
CompletedMay 31, 2023
May 1, 2023
1.1 years
January 20, 2022
May 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of Adverse Events (AEs)
Up to 12 Months
Incidence of Serious Adverse Events (SAEs)
Up to 12 Months
Incidence of Adverse Drug Reactions (ADRs)
Up to 12 Months
Secondary Outcomes (1)
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 Arms (2)
Retrospectively enrolled cohort
Participants who initiate Azacitidine (AZA) before enrollment
Prospectively enrolled cohort
Participants who initiate AZA initiation at enrollment
Eligibility Criteria
The study population will consist of participants enrolled retrospectively, who initiate azacitidine (AZA) before enrollment and participants enrolled prospectively, who initiate AZA initiation at enrollment.
You may qualify if:
- 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
You may not qualify if:
- Contraindicated for the use of AZA according to China Product Label
- Simultaneously participating in a treatment intervention study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Tianjin, Tianjin Municipality, 300010, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2022
First Posted
February 1, 2022
Study Start
February 25, 2022
Primary Completion
March 20, 2023
Study Completion
March 20, 2023
Last Updated
May 31, 2023
Record last verified: 2023-05