Status:
TERMINATED
US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Hairy Cell Leukemia
Eligibility:
All Genders
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...
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 refract...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04125290
Start Date
December 9 2019
End Date
June 21 2021
Last Update
July 18 2025
Active Locations (2)
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1
Rocky Mountain Cancer Centers
Pueblo, Colorado, United States, 81008
2
Research Site
Bridgeton, Missouri, United States, 63044