The Real World Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

NCT06489184 | Not Yet Recruiting FDA Drug

• 1 other identifier: 2024Zanu-RW-01
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China

Conditions

CLL

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the duration from date of Zanubrutinib initiation to date of disease progression (PD \[according to the physician's evaluation\]) or death from any cause

  up to two years

Secondary Outcomes (3)

• Overall Survival

  up to two years

• Time to Next Therapy (TTNT)

  up to two years

• Adverse Events

  up to two years

Interventions

Zanubrutinib DRUG

patients with treatment naive or R/R CLL who treatment with Zanubrutinib

Eligibility Criteria

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

Study Population

Investigators participating in this observational study should include all patients with CLL who initiated treatment with zanubrutinib over the period from July 1st, 2020 to the present, regardless of the treatment status at the time of inclusion. Thus, at the time of enrolment and retrospective data collection, patients may still be on treatment or have stopped treatment for any reason.

You may qualify if:

• \. Patients aged ≥18 years old
• \. Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL \[International Workshop on Chronic Lymphocytic Leukemia\] criteria)；
• \. Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on Zanubrutinib;
• Prior or current use of Zanubrutinib for ≥3 months
• At least one follow-up was recorded during Zanubrutinib treatment

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Interventions

zanubrutinib

Central Study Contacts

Shenmiao Yang

CONTACT

yangshenmiao@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 30, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-06

Locations

CN (1)