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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

Must not have

Clinically significant third space fluid accumulation unless proven by cytology to be malignant due to WM

Concurrent systemic immunosuppressant therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have fluid build-up that isn't cancerous, related to Waldenström's macroglobulinemia.

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I am currently on medication that suppresses my immune system.

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I have a serious heart condition.

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I have not had major surgery in the last 4 weeks.

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I have been treated with a CD19 targeted therapy before.

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I finished treatment for an infection less than 14 days ago.

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I have been diagnosed with lymphoma in my central nervous system.

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I have side effects from previous treatments that are not severe.

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I have a significant history of liver disease.

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I have HIV or chronic hepatitis B or C and am receiving treatment for it.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Bone marrow response

Impact of loncastuximab tesirine in the participants' quality of life

Number of Participants With Complete Response

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2650