Myelodysplastic SyndromesDIM VidazaNCT05218902
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 of Myelodysplastic Syndromes and Leukemia, Myelomonocytic, Chronic, run by Bristol-Myers Squibb at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2022to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Keywords
- Myelodysplastic syndromes (MDS), Azacitidine (AZA), Chronic myelomonocytic leukemia (CMML), Acute myeloid leukemia (AML)
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospectively enrolled cohort | Participants who initiate Azacitidine (AZA) before enrollment | |
| Prospectively enrolled cohort | Participants who initiate AZA initiation at enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Up to 12 Months
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 12 Months
Incidence of Adverse Drug Reactions (ADRs)
Measured: 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
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start25 Feb 2022
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218902
- Sponsor's protocol ID
- CA055-016
- Acronym
- DIM Vidaza
- Status last verified
- May 2023
- First submitted
- 20 Jan 2022
- Last updated
- 31 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05218902
- Acronym / sponsor ID
- DIM Vidaza / CA055-016
- Keywords
- Myelodysplastic syndromes (MDS), Azacitidine (AZA), Chronic myelomonocytic leukemia (CMML), Acute myeloid leukemia (AML)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospectively enrolled cohort | – | –Participants who initiate Azacitidine (AZA) before enrollment |
| Prospectively enrolled cohort | – | –Participants who initiate AZA initiation at enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 12 Months
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 12 Months
Incidence of Adverse Drug Reactions (ADRs)
Time frame: Up to 12 Months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Leukemia, Myelomonocytic, Chronic, run by Bristol-Myers Squibb at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Up to 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.