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)

NCT ID: NCT05218902

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-25

Study Completion Date

2023-03-20

Brief Summary

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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

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

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospectively enrolled cohort

Participants who initiate Azacitidine (AZA) before enrollment

No interventions assigned to this group

Prospectively enrolled cohort

Participants who initiate AZA initiation at enrollment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Related Links

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Other Identifiers

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CA055-016

Identifier Type: -

Identifier Source: org_study_id

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