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

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ClinicalTrials.gov Identifier: NCT04125290
Recruitment Status : Not yet recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date September 13, 2019
First Posted Date October 14, 2019
Last Update Posted Date October 14, 2019
Estimated Study Start Date December 1, 2019
Estimated Primary Completion Date September 11, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2019)
  • Incident proportion of capillary leak syndrome [ Time Frame: 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 [ Time Frame: From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk. ]
  • Incident proportion of renal toxicity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
  • Incident proportion of other medical events related to moxetumomab pasudotox-tdfk interruption or discontinuation [ Time Frame: 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 [ Time Frame: From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk. ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)
Official Title US Post-Marketing Retrospective Observational Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)(TM)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population will be patients who are prescribed moxetumomab-pasudotox-tdfk who are ≥65 years old at the time of starting initial treatment with moxetumomab pasudotox-tdfk or are ≥18 years old with moderate renal impairment defined as an estimated GFR of 30-59 ml/min, at the time of starting initial treatment with moxetumomab pasudotox-tdfk. These two populations may not be mutually exclusive.
Condition Hairy Cell Leukemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 11, 2019)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 11, 2023
Estimated Primary Completion Date September 11, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04125290
Other Study ID Numbers D3143R00004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Iqvia Pty Ltd
Investigators
Study Director: Katherine Ruffner, MD Acerta Pharma, LLC
Study Director: Katherine Coyle, PharmD AstraZeneca
PRS Account AstraZeneca
Verification Date October 2019