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

TerminatedN/A

Sponsor: AstraZeneca

Conditions: Hairy Cell Leukemia

Countries: United States

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

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (2)

Pueblo, Colorado, United States
Bridgeton, Missouri, United States