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

NCT04125290 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2025-07-18

No results posted yet for this study

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

Conditions

  • Hairy Cell Leukemia

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Archna Hale · AstraZeneca

  • Juan Cuevas · SSM Health DePaul Hospital

  • Travis Arculeta · Rocky Mountain Cancer Centers

  • Roser Calvo · AstraZeneca

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-09
Primary Completion
2021-06-21
Completion
2021-06-21

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04125290 on ClinicalTrials.gov