PROXY: US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04125290
Collaborator
Iqvia Pty Ltd (Industry)
2
2
47.7
1
0

Study Details

Study Description

Brief Summary

This study is being conducted to satisfy a post-marketing requirement (PMR) to provide evidence characterizing 1) the safety of moxetumomab pasudotox-tdfk in patients who are 65 years of age and older and/or 2) the safety of moxetumomab pasudotox-tdfk in patients who have moderate renal impairment defined as an estimated GFR of 30-59 ml/min

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The pivotal Phase 3 study (Study 1053) supported full approval of moxetumomab pasudotox-tdfk from the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a PNA, on 13 September 2018. Since HCL is a rare disease, clinical research has limited information concerning the safety of moxetumomab pasudotox-tdfk in elderly patient populations and patients with moderate renal impairment.This study is being conducted to satisfy a post-marketing requirement (PMR) to provide evidence characterizing the safety of moxetumomab in these patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    US Post-Marketing Retrospective Observational Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)(TM)
    Actual Study Start Date :
    Dec 9, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incident proportion of capillary leak syndrome [From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.]

    2. Incident proportion of hemolytic uremic syndrome [From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.]

    3. Incident proportion of renal toxicity [From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.]

    4. Incident proportion of infusion related reactions [From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.]

    5. Incident proportion of electrolyte and biochemical abnormalities [From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.]

      Electrolyte and biochemical abnormalities are defined as laboratory measurements of interest that exceed local laboratory standards

    6. Incident proportion of other medical events related to moxetumomab pasudotox-tdfk interruption or discontinuation [From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.]

    7. Incident proportion of other serious medical events that are life-threatening, resulting in hospitalizations and/or death [From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Provision of written informed consent, if required

    • Patient received at least 1 dose of moxetumomab pasudotox-tdfk and has completed or discontinued the treatment

    • Patient has a medical record available from the start of first dose of moxetumomab pasudotox tdfk

    AND at least 1 of the following:
    • Patient is ≥65 years old at the time of starting initial treatment with moxetumomab pasudotox-tdfk OR

    • Adult (≥18 years old) patient has moderate renal impairment, at the time of starting initial treatment with moxetumomab pasudotox-tdfk

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rocky Mountain Cancer Centers Pueblo Colorado United States 81008
    2 Research Site Bridgeton Missouri United States 63044

    Sponsors and Collaborators

    • AstraZeneca
    • Iqvia Pty Ltd

    Investigators

    • Study Director: Archna Hale, AstraZeneca
    • Principal Investigator: Juan Cuevas, SSM Health DePaul Hospital
    • Principal Investigator: Travis Arculeta, Rocky Mountain Cancer Centers
    • Study Director: Roser Calvo, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04125290
    Other Study ID Numbers:
    • D3143R00004
    First Posted:
    Oct 14, 2019
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022

    Study Results

    No Results Posted as of Aug 19, 2022