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OpenTrials
Completed

NCT Number: NCT05218902

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)

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.

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Chronic Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Tianjin, Tianjin Municipality, 300010, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: DIM Vidaza

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2022
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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