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

Hairy Cell Leukemia Clinical Trial

— PROXY  

Official title:

US Post-Marketing Retrospective Observational Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)(TM)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04125290
• Other study ID #: D3143R00004
• Status: Terminated
• Start date: December 9, 2019
• Est. completion date: June 21, 2021

Study information

• Verified date: April 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hairy Cell Leukemia
• Leukemia, Hairy Cell

Locations

Country	Name	City	State
United States	Research Site	Bridgeton	Missouri
United States	Rocky Mountain Cancer Centers	Pueblo	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Iqvia Pty Ltd

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bouroncle BA. Thirty-five years in the progress of hairy cell leukemia. Leuk Lymphoma. 1994;14 Suppl 1:1-12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Incident proportion of renal toxicity		From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.
Primary	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.
Primary	Incident proportion of electrolyte and biochemical abnormalities	Electrolyte and biochemical abnormalities are defined as laboratory measurements of interest that exceed local laboratory standards	From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.
Primary	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.
Primary	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.