DIM Vidaza: 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)

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05218902
• Collaborator: (none)
• Enrollment: 300
• Locations: 3
• Anticipated Duration (Months): 28.1
• Patients Per Site: 100
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute

Detailed Description

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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
• Actual Study Start Date: Feb 25, 2022
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Retrospectively enrolled cohort Participants who initiate Azacitidine (AZA) before enrollment
Prospectively enrolled cohort Participants who initiate AZA initiation at enrollment

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events (AEs) [Up to 12 Months]

2. Incidence of Serious Adverse Events (SAEs) [Up to 12 Months]

3. Incidence of Adverse Drug Reactions (ADRs) [Up to 12 Months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution - 0001	Tianjin	Tianjin	China	300010
2	Local Institution - 0002	Tianjin		China	300052
3	Local Institution - 0003	Tianjin		China	300060

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05218902
• Other Study ID Numbers: CA055-016
• First Posted: Feb 1, 2022
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Bristol-Myers Squibb: Myelodysplastic syndromes (MDS); Azacitidine (AZA); Chronic myelomonocytic leukemia (CMML); Acute myeloid leukemia (AML)
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome

Study Results

No Results Posted as of Jun 30, 2022