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Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants Above 19 Years of Age With Acute Myeloid Leukemia (AML)

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AbbVie

Status

Completed

Conditions

Acute Myeloid Leukemia (AML)

Study type

Observational

Funder types

Industry

Identifiers

NCT04826523
P20-444

Details and patient eligibility

About

Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective oral venetoclax is in participants with AML . Adverse events and change in disease activity will be monitored under routine clinical practice.

Venetoclax is an approved drug for treatment of Acute Myeloid Leukemia (AML). Around 600 participants of age 19 years and above will be enrolled in the study in multiple medical institutions across South Korea.

Participants will receive oral venetoclax tablets as prescribed by their physician in the routine clinical practice. Participants will be observed for 7 cycles ( each cycle is 28 days).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Enrollment

150 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

--Acute Myeloid Leukemia (AML) participants who have been prescribed oral Venetoclax tablets for the first time according to the approved label.

Exclusion criteria

  • Participants with contraindications to Venetoclax as listed on the approved local label.
  • Participants receiving Venetoclax in clinical trials.

Trial design

150 participants in 1 patient group

Participants treated with Venetoclax
Description:
Participants who were prescribed venetoclax for the treatment of Acute Myeloid Leukemia (AML) will be enrolled for this study.

Trial contacts and locations

10

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Central trial contact

ABBVIE CALL CENTER; Hyunjung Kim

Data sourced from clinicaltrials.gov

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