NCT04125290

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

September 13, 2019

Last Update Submit

July 16, 2025

Conditions

Hairy Cell Leukemia

Keywords

capillary leak syndromehemolytic uremic syndromerenal toxicityinfusion-related reactionelectrolyte abnormalitiesHCL and all relevant indications where LUMOXITI will be prescribed

Outcome Measures

Primary Outcomes (7)

  • 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

    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.

  • 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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rocky Mountain Cancer Centers

Pueblo, Colorado, 81008, United States

Location

Research Site

Bridgeton, Missouri, 63044, United States

Location

Related Publications (8)

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

    PMID: 7820038BACKGROUND

  • 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.

    PMID: 17237035BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 11399570BACKGROUND

  • 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.

    PMID: 9001435BACKGROUND

  • 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.

    PMID: 19064987BACKGROUND

  • 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.

    PMID: 7910051BACKGROUND

  • 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.

    PMID: 9001417BACKGROUND

Related Links

MeSH Terms

Conditions

Leukemia, Hairy CellCapillary Leak SyndromeHemolytic-Uremic Syndrome

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesVascular DiseasesCardiovascular DiseasesUremiaKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAnemia, HemolyticAnemiaThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopenia

Study Officials

  • Archna Hale

    AstraZeneca

    STUDY DIRECTOR

  • Juan Cuevas

    SSM Health DePaul Hospital

    PRINCIPAL INVESTIGATOR

  • Travis Arculeta

    Rocky Mountain Cancer Centers

    PRINCIPAL INVESTIGATOR

  • Roser Calvo

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2019

First Posted

October 14, 2019

Study Start

December 9, 2019

Primary Completion

June 21, 2021

Study Completion

June 21, 2021

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations

US(2)