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

NCT06557304 | Not Yet Recruiting FDA Drug

• 1 other identifier: BTKi-CLL-RWE
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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)

• Overall Survival

  OS is defined as the time from the starting date of BTK inhibitor to the date of death due to any cause.

  up to five years

Secondary Outcomes (2)

• Time to Next Therapy (TTNT)

  up to two years

• Adverse Events

  up to five years

Interventions

BTK inhibitor DRUG

patients with treatment naive or R/R CLL who treatment with BTK inhibitor

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 BTK inhibitor over the period from Dec. 1st, 2017 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 BTK inhibitor;
• Prior or current use of BTK inhibitor for ≥3 months
• At least one follow-up was recorded during BTK inhibitor treatment

Sponsors & Collaborators

• Peking University People's Hospital: lead

Central Study Contacts

Shengmiao Yang, MD

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: August 13, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 21, 2024

Record last verified: 2024-08