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

ConditionCLL
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • BTK inhibitor

    Drug

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

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
up to five years

Secondary outcomes

1

Time to Next Therapy (TTNT)

The TTNT will be calculated as the difference between BTK inhibitor initiation date and initiation date of the first next therapy for CLL

Time frame
up to two years
2

Adverse Events

Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations

Time frame
up to five years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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