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BESPONSA Injection 1 mg Special Investigation

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05923112
Collaborator
(none)
200
Enrollment
1
Location
70.3
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia.

Registration criteria for this study is all patients who starting BESPONSA from its launch to the market to April 30, 2020.

All patients in this study will receive BESPONSA according to the prescriptions.

Patients will be followed up as follow.

  • 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA.

  • Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    BESPONSA® INJECTION 1 MG SPECIAL INVESTIGATION
    Actual Study Start Date :
    Jul 2, 2018
    Anticipated Primary Completion Date :
    May 10, 2024
    Anticipated Study Completion Date :
    May 10, 2024

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of adverse drug reactions [Up to 52 weeks]

      The observation period will be 52 weeks for patients not undergoing HSCT within 52 weeks after the start of BESPONSA treatment or until 52 weeks following HSCT for patients undergoing it within 52 weeks after the start of BESPONSA treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients prescribed BESPONSA
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Tokyo Japan

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05923112
    Other Study ID Numbers:
    • B1931024
    First Posted:
    Jun 28, 2023
    Last Update Posted:
    Jun 28, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pfizer
    Drug use investigation in Japan
    Additional relevant MeSH terms:
    Precursor Cell Lymphoblastic Leukemia-Lymphoma

    Study Results

    No Results Posted as of Jun 28, 2023