PROXY: US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)
Study Details
Study Description
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 | Intervention/Treatment | Phase |
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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 Design
Outcome Measures
Primary Outcome Measures
- 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 [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 [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.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of written informed consent, if required
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Patient received at least 1 dose of moxetumomab pasudotox-tdfk and has completed or discontinued the treatment
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Patient has a medical record available from the start of first dose of moxetumomab pasudotox tdfk
AND at least 1 of the following:
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Patient is ≥65 years old at the time of starting initial treatment with moxetumomab pasudotox-tdfk OR
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Adult (≥18 years old) patient has moderate renal impairment, at the time of starting initial treatment with moxetumomab pasudotox-tdfk
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Rocky Mountain Cancer Centers | Pueblo | Colorado | United States | 81008 |
2 | Research Site | Bridgeton | Missouri | United States | 63044 |
Sponsors and Collaborators
- AstraZeneca
- Iqvia Pty Ltd
Investigators
- Study Director: Archna Hale, AstraZeneca
- Principal Investigator: Juan Cuevas, SSM Health DePaul Hospital
- Principal Investigator: Travis Arculeta, Rocky Mountain Cancer Centers
- Study Director: Roser Calvo, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
- Bouroncle BA. Thirty-five years in the progress of hairy cell leukemia. Leuk Lymphoma. 1994;14 Suppl 1:1-12. Review.
- Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66.
- Kreitman 2018, Leukemia https://doi.org/10.1038/s41375-018-0210-1
- Kreitman RJ, Cheson BD. Malignancy: Current Clinical Practice: Treatment of Hairy Cell Leukemia at the Close of the 20th Century. Hematology. 1999;4(4):283-303.
- Kroft SH, Tallman MS, Shaw JM, Thangavelu M, Peterson LC. Myelodysplasia following treatment of chronic lymphocytic leukemia (CLL) with 2-chlorodeoxyadenosine (2-CdA). Leukemia. 1997 Jan;11(1):170.
- Leleu X, Soumerai J, Roccaro A, Hatjiharissi E, Hunter ZR, Manning R, Ciccarelli BT, Sacco A, Ioakimidis L, Adamia S, Moreau AS, Patterson CJ, Ghobrial IM, Treon SP. Increased incidence of transformation and myelodysplasia/acute leukemia in patients with Waldenström macroglobulinemia treated with nucleoside analogs. J Clin Oncol. 2009 Jan 10;27(2):250-5. doi: 10.1200/JCO.2007.15.1530. Epub 2008 Dec 8.
- Seymour JF, Kurzrock R, Freireich EJ, Estey EH. 2-chlorodeoxyadenosine induces durable remissions and prolonged suppression of CD4+ lymphocyte counts in patients with hairy cell leukemia. Blood. 1994 May 15;83(10):2906-11.
- Seymour JF, Talpaz M, Kurzrock R. Response duration and recovery of CD4+ lymphocytes following deoxycoformycin in interferon-alpha-resistant hairy cell leukemia: 7-year follow-up. Leukemia. 1997 Jan;11(1):42-7.
- D3143R00004