Pharmacokinetics of Venetoclax in Patients With Acute Myeloid Leukemia

NCT04613622 | Unknown FDA Drug

• 1 other identifier: 202007124RIND
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Venetoclax is a treatment for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). However, the pharmacokinetic data in Chinese population, as well as the change of venetoclax plasma concentration while taking CYP enzyme inducers or inhibitors, remained unknown so far. Therefore, the aim of this study is to investigate the pharmacokinetic characteristics of venetoclax.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• Area under curve (AUC) of venetoclax in Chinese population

  Area under curve (AUC) will be calculated through multiple plasma concentrations drawn from the patients after taking venetoclax.

  August 1, 2020 to December 31, 2025

• Half-life (T1/2) of venetoclax in Chinese population

  Half-life (T1/2) will be calculated through multiple plasma concentrations drawn from the patients after taking venetoclax.

  August 1, 2020 to December 31, 2025

• Clearance (CL) of venetoclax in Chinese population

  Clearance (CL) will be calculated through multiple plasma concentrations drawn from the patients after taking venetoclax.

  August 1, 2020 to December 31, 2025

Secondary Outcomes (3)

• Analysis of venetoclax plasma concentration with concomitant CYP enzyme inhibitors or inducers

  August 1, 2020 to December 31, 2025

• Association between venetoclax plasma concentration and therapeutic effectiveness, adverse events

  August 1, 2020 to December 31, 2025

• Establishment of venetoclax clinical dose adjustment

  August 1, 2020 to December 31, 2025

Study Arms (1)

Venetoclax

Adult patients (≥ 20 year-old) who have already initiated or are going to receive venetoclax treatment at National Taiwan University Hospital/National Taiwan University Cancer Center from August 2020 to December 2025.

Drug: Venetoclax

Interventions

Venetoclax DRUG

This prospective study will draw blood from every patient to measure the venetoclax blood concentration. After blood concentration analysis by ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS), the investigator will report the concentration to clinicians.

Venetoclax

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 20 year-old) who have already initiated or are going to receive venetoclax treatment at National Taiwan University Hospital/National Taiwan University Cancer Center from August 2020 to December 2025.

You may qualify if:

• Adult patients (≥ 20 year-old)
• Patients who meet the above criteria and have already initiated or are going to receive venetoclax treatment at National Taiwan University Hospital/National Taiwan University Cancer Center from August 2020 to December 2025

You may not qualify if:

• Patients who are unable to cooperate with blood drawing
• Patients who have not submit the informed consent

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Shu-Wen Lin, Pharm.D

CONTACT

886-2-33668782; shuwenlin@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 3, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)