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Trial record 34 of 37 for:    Acerta Pharma

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

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.

Condition or disease
Hairy Cell Leukemia

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 .

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: US Post-Marketing Retrospective Observational Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)(TM)
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : September 11, 2023
Estimated Study Completion Date : September 11, 2023





Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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

  6. 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. ]
  7. 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. ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125290


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Sponsors and Collaborators
AstraZeneca
Iqvia Pty Ltd
Investigators
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Study Director: Katherine Ruffner, MD Acerta Pharma, LLC
Study Director: Katherine Coyle, PharmD AstraZeneca

Publications:
Kreitman 2018, Leukemia https://doi.org/10.1038/s41375-018-0210-1

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04125290     History of Changes
Other Study ID Numbers: D3143R00004
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
capillary leak syndrome
hemolytic uremic syndrome
renal toxicity
infusion-related reaction
electrolyte abnormalities
HCL and all relevant indications where LUMOXITI will be prescribed
Additional relevant MeSH terms:
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Leukemia, Hairy Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunotoxin HA22
Antineoplastic Agents