US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)
NCT ID: NCT04125290
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2 participants
OBSERVATIONAL
2019-12-09
2021-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Archna Hale
Role: STUDY_DIRECTOR
AstraZeneca
Juan Cuevas
Role: PRINCIPAL_INVESTIGATOR
SSM Health DePaul Hospital
Travis Arculeta
Role: PRINCIPAL_INVESTIGATOR
Rocky Mountain Cancer Centers
Roser Calvo
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Rocky Mountain Cancer Centers
Pueblo, Colorado, United States
Research Site
Bridgeton, Missouri, United States
Countries
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References
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Bouroncle BA. Thirty-five years in the progress of hairy cell leukemia. Leuk Lymphoma. 1994;14 Suppl 1:1-12.
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. doi: 10.3322/canjclin.57.1.43.
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. doi: 10.1080/10245332.1999.11746452.
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. doi: 10.1038/sj.leu.2400523. No abstract available.
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 Waldenstrom 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. doi: 10.1038/sj.leu.2400513.
Related Links
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Other Identifiers
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D3143R00004
Identifier Type: -
Identifier Source: org_study_id
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