the Real World Study of Orelabrutinib in the Treatment of CLL/SLL

July 26, 2023 updated by: Chunyan Ji, Shandong University

A Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Orelabrutinib is a novel BTK inhibitor with high selectivity and has been approved in China for relapsed/refractory CLL/SLL,, The purpose of this study is to describe the effectiveness and safety of orelabrutinib of chronic lymphocytic leukemia (CLL) in real world.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who received orelabrutinib in real world

Description

Inclusion Criteria:

  1. Age ≥18 years old
  2. Patients with a definite diagnosis of CLL/SLL
  3. Prior or current use of orelabrutinib for ≥3 months
  4. At least one follow-up was recorded during orelabrutinib treatment

Exclusion Criteria:

1.Patients who received orelabrutinib in a prospective clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: up to two years
The ORR will be calculated as the proportion of participants who achieve either complete response (CR), partial response (PR) or partial response with lymphocytosis, as assessed by the participating physician.
up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Next Therapy (TTNT)
Time Frame: up to two years
The TTNT will be calculated as the difference betweenorelabrutinib initiation date and initiation date of the first next therapy for CLL
up to two years
Progression Free Survival (PFS)
Time Frame: up to two years
PFS is defined as the duration from date of orelabrutinib initiation to date of disease progression (PD [according to the physician's evaluation]) or death from any cause
up to two years
response rate of Hematologic Parameters
Time Frame: up to two years
the proportion of participants who had abnormal baseline hemoglobin, or platelet, or lymphocyte counts returned to normal levels or had ≥50% increases in hemoglobin and platelets or ≥50% decreases in lymphocyte counts
up to two years
safety
Time Frame: up to two years
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Chunyan Ji, Dr., Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2023

Primary Completion (Estimated)

December 10, 2023

Study Completion (Estimated)

July 10, 2024

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Orelabrutinib in real world

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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