Bridgeton, Missouri 63044

  • Hairy Cell Leukemia

Purpose:

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.


Study summary:

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 .


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


NCT ID:

NCT04125290


Primary Contact:

Study Director
Emmanuel Mitry, MD
Innate Pharma

Innate Pharma Mitry Emmanuel, MD
Phone: +33430303197
Email: emmanuel.mitry@innate-pharma.fr


Backup Contact:

Email: lucile.beautier@innate-pharma.fr
Lucile Beautier
Phone: +33430303197


Location Contact:

Bridgeton, Missouri 63044
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 30, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.