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

Study Overview
=================
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.

Official Title
-----------------
US Post-Marketing Retrospective Observational Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)(TM)

Conditions
-----------------
Hairy Cell Leukemia

Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 renal toxicity |  | 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 electrolyte and biochemical abnormalities | Electrolyte and biochemical abnormalities are defined as laboratory measurements of interest that exceed local laboratory standards | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capillary leak syndrome, hemolytic uremic syndrome, renal toxicity, infusion-related reaction, electrolyte abnormalities, HCL and all relevant indications where LUMOXITI will be prescribed