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CompletedNCT05218902DIM VidazaUpdated May 31, 2023

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)

An observational study in Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic and Leukemia, Myeloid, Acute, sponsored by Bristol-Myers Squibb. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
290
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study will have participants both enrolled retrospectively and prospectively for azacitidine (AZA) treatment.

02

Conditions studied

  • Myelodysplastic Syndromes
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myeloid, Acute

Keywords

  • Myelodysplastic syndromes (MDS)
  • Azacitidine (AZA)
  • Chronic myelomonocytic leukemia (CMML)
  • Acute myeloid leukemia (AML)
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 290 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

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

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.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
290 participants (actual)
Patient registry
No

Groups and cohorts

  • Retrospectively enrolled cohort

    Participants who initiate Azacitidine (AZA) before enrollment

  • Prospectively enrolled cohort

    Participants who initiate AZA initiation at enrollment

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 12 Months

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 12 Months

  3. Incidence of Adverse Drug Reactions (ADRs)

    Time frame: 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

    Time frame: Up to 12 Months

07

Study locations

1 site
  • Local Institution - 0001
    Tianjin, Tianjin 300010, China
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05218902
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Feb 1, 2022
Start date
Feb 25, 2022
Primary completion
Mar 20, 2023
Completion
Mar 20, 2023
Last update
May 31, 2023

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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