NCT04616274

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

5.5 years

First QC Date

November 2, 2020

Last Update Submit

October 27, 2021

Conditions

Chronic Lymphocytic 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.

    July 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.

    July 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.

    July 1, 2020 to December 31, 2025

Secondary Outcomes (3)

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

    July 1, 2020 to December 31, 2025

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

    July 1, 2020 to December 31, 2025

  • Establishment of venetoclax clinical dose adjustment

    July 1, 2020 to December 31, 2025

Study Arms (1)

Venetoclax

Adult CLL 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 July 2020 to December 2025.

Drug: Venetoclax

Interventions

VenetoclaxDRUG

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

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult chronic lymphocytic leukemia 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) with diagnosis of chronic lymphocytic leukemia
  • 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 July 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Shu-Wen Lin, Pharm.D

CONTACT

886-2-33668782shuwenlin@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

November 2, 2020

First Posted

November 4, 2020

Study Start

July 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)