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Monoclonal Antibodies

Loncastuximab Tesirine + Dexamethasone for Waldenstrom Macroglobulinemia

Phase 2

Recruiting

Research Sponsored by Shayna Sarosiek, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum serum IgM level of > 2 times the upper limit normal

Normal organ and marrow function as defined: Absolute neutrophil count ≥1000/ uL, Platelets ≥50,000/ uL, Hemoglobin ≥ 7 g/dL, Total bilirubin ≤ 1.5 X ULN, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, Creatinine clearance ≥ 30 ml/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is being conducted to study the safety and efficacy of the aforementioned drug in patients with Waldenström macroglobulinemia.

Who is the study for?

Adults with Waldenström Macroglobulinemia (WM) who have had at least two prior treatments, including an anti-CD20 monoclonal antibody and a BTK inhibitor. They must not be pregnant or breastfeeding, have good organ function, no recent major surgery or infections, and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of loncastuximab tesirine for WM treatment. Participants will receive this drug alongside dexamethasone to see if it helps manage their condition better than current treatments.See study design

What are the potential side effects?

Potential side effects of loncastuximab tesirine may include reactions at the injection site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. Dexamethasone can cause mood swings, blood sugar increases, and insomnia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood test shows high levels of IgM, more than twice the normal limit.

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You need to have normal levels of white blood cells, platelets, hemoglobin, bilirubin, liver enzymes, and kidney function.

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I have had at least 2 treatments including anti-CD20 and BTK inhibitor therapies.

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My condition requires treatment according to specific expert guidelines.

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I have been diagnosed with Waldenström Macroglobulinemia.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate

Secondary outcome measures

Bone marrow response

Impact of loncastuximab tesirine in the participants' quality of life

Number of Participants With Complete Response

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Loncastuximab Tesirine + DexamethasoneExperimental Treatment2 Interventions

Participants will be given Loncastuximab Tesirine on Day 1 of every 28 day study cycle and continue for up to 6 cycles. Participants will also receive pre-medications to reduce the chance of having a sensitivity reaction to the study treatment. Participants who tolerate the study treatment without a reaction may have pre-medications changed per determination of their doctor. Dexamethasone will be given prior to study treatment on Day -1 or up to 2 hours prior to loncastuximab tesirine and the day after treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Loncastuximab Tesirine

2022

Completed Phase 2

~50

Dexamethasone

2007

Completed Phase 4

~2590

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shayna Sarosiek, MDLead Sponsor

1 Previous Clinical Trials

33 Total Patients Enrolled

1 Trials studying Waldenstrom Macroglobulinemia

33 Patients Enrolled for Waldenstrom Macroglobulinemia

ADC Therapeutics S.A.Industry Sponsor

28 Previous Clinical Trials

2,197 Total Patients Enrolled

1 Trials studying Waldenstrom Macroglobulinemia

183 Patients Enrolled for Waldenstrom Macroglobulinemia

Media Library

Waldenstrom Macroglobulinemia Clinical Trial 2023: Loncastuximab Tesirine Highlights & Side Effects. Trial Name: NCT05190705 — Phase 2

Loncastuximab Tesirine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05190705 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Loncastuximab Tesirine received government sanctioning for patient use?

"Given that this is a Phase 2 trial (i.e. there is some data supporting safety, but none yet for efficacy), our team has given Loncastuximab Tesirine a score of 2 in terms of safety."

Answered by AI

What conditions does Loncastuximab Tesirine commonly treat?

"Loncastuximab Tesirine can be used to improve symptoms and vision for patients that suffer from ophthalmia, sympathetic, branch retinal vein occlusion, or macular edema."

Answered by AI

Are we currently enrolling patients for this research project?

"The clinical trial is currently looking for patients, according to the information on clinicaltrials.gov. This study was first posted on February 17th, 2022 and has been edited most recently on November 15th, 2022. They are searching for a total of 36 participants who would ideally be split between 2 locations."

Answered by AI

How many people are being allowed to enroll in this clinical trial?

"The clinical trial is still recruiting participants, as shown by the information on clinicaltrials.gov. This specific study was posted on 2/17/2022 and updated on 11/15/2022. They are looking for a total of 36 participants that will be split between 2 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Loncastuximab Tesirine in WM

Shayna Sarosiek, MD 2022. "Loncastuximab Tesirine in WM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05190705.

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