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

Sponsor
Shandong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05975164
Collaborator
(none)
50
Enrollment
11.5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
    Anticipated Study Start Date :
    Jul 25, 2023
    Anticipated Primary Completion Date :
    Dec 10, 2023
    Anticipated Study Completion Date :
    Jul 10, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) [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.

    Secondary Outcome Measures

    1. Time to Next Therapy (TTNT) [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

    2. Progression Free Survival (PFS) [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

    3. response rate of Hematologic Parameters [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

    4. safety [up to two years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shandong University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chunyan Ji, Prof., Shandong University
    ClinicalTrials.gov Identifier:
    NCT05975164
    Other Study ID Numbers:
    • Orelabrutinib in real world
    First Posted:
    Aug 3, 2023
    Last Update Posted:
    Aug 3, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 3, 2023