ClinicalTrials.Veeva

Menu

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) (DIM Vidaza)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

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

Study type

Observational

Funder types

Industry

Identifiers

NCT05218902
CA055-016

Details and patient eligibility

About

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.

Full description

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

Enrollment

290 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

290 participants in 2 patient groups

Retrospectively enrolled cohort
Description:
Participants who initiate Azacitidine (AZA) before enrollment
Prospectively enrolled cohort
Description:
Participants who initiate AZA initiation at enrollment

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems