NCT05975164

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

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 25, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

July 26, 2023

Last Update Submit

July 26, 2023

Conditions

CLL/SLL

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    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 Outcomes (4)

  • Time to Next Therapy (TTNT)

    up to two years

  • Progression Free Survival (PFS)

    up to two years

  • response rate of Hematologic Parameters

    up to two years

  • safety

    up to two years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who received orelabrutinib in real world

You may qualify if:

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

You may not qualify if:

  • Patients who received orelabrutinib in a prospective clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Chunyan Ji, Dr.

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Li

CONTACT

18560089739liwei_medicine@163.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

July 26, 2023

First Posted

August 3, 2023

Study Start

July 25, 2023

Primary Completion

December 10, 2023

Study Completion

July 10, 2024

Last Updated

August 3, 2023

Record last verified: 2023-07