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

Terminated

• Conditions: Hairy Cell Leukemia

• Registration Number: NCT04125290
• Lead Sponsor: AstraZeneca

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

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 Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Study Start: 2019-12-09
• Primary Completion: 2021-06-21
• Study Completion: 2021-06-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
Incident proportion of renal toxicity	From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.
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.
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.
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

Trial Locations

Locations (2)

Rocky Mountain Cancer Centers; 🇺🇸 Pueblo, Colorado, United States

Research Site; 🇺🇸 Bridgeton, Missouri, United States