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

Stopped early

Conditions studied: Hairy Cell Leukemia

In brief

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

Key facts

Study ID

NCT04125290

Run by

AstraZeneca

People needed

2

Starts

2019-12-09

Expected to finish

2021-06-21

Last updated by the study team

2025-07-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Rocky Mountain Cancer Centers — Pueblo, Colorado, United States
• Research Site — Bridgeton, Missouri, United States

Full record on ClinicalTrials.gov

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