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Monoclonal Antibodies

Epcoritamab for Waldenstrom Macroglobulinemia

Phase 2

Recruiting

Led By Gottfried von Keudell, MD

Research Sponsored by Gottfried von Keudell, MD PhD

Eligibility Criteria Checklist

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

Must have

Diagnosis of lymphoplasmacytic lymphoma/WM that is CD20+ by immunophenotype or immunohistochemistry confirmed by bone marrow biopsy/aspirate

Age ≥18 years

Must not have

Symptomatic or suspected hyperviscosity syndrome or IgM levels > 4000 mg/dL without ability to undergo plasmapheresis

Uncontrolled active infection requiring hospitalization or intravenous antimicrobial agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate whether a drug called epcoritamab can effectively treat individuals who have previously been treated for Waldenstrom Macroglobulinemia. Epcoritamab

Who is the study for?

This trial is for individuals with Waldenstrom Macroglobulinemia (WM), a type of B-cell lymphoma, who have already undergone treatment. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

What is being tested?

The trial is testing Epcoritamab, an antibody designed to target and kill cancer cells in patients with WM who have previously been treated. The goal is to see if this drug is effective as a new therapy option for these patients.

What are the potential side effects?

While specific side effects for Epcoritamab are not listed here, antibodies like it can sometimes cause reactions at the infusion site, fever, chills, nausea, fatigue, and allergic responses among others.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma is CD20 positive, confirmed by a bone marrow test.

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I am 18 years old or older.

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I have been treated with an anti-CD20 antibody and a BTK inhibitor before.

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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 do not have active Hepatitis B or C.

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I have HIV, am on stable treatment, my viral load is undetectable, and my CD4 count is over 250.

Exclusion Criteria

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

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I have symptoms of thick blood or high IgM levels and cannot have plasmapheresis.

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I do not have an active infection that needs hospital care or IV antibiotics.

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I do not have uncontrolled heart or brain conditions.

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I need extra oxygen to keep my blood oxygen level above 92%.

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My cancer has spread to my brain or spinal cord.

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I have not had a live vaccine in the last 4 weeks.

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My lymphoma has become more aggressive.

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I have no severe side effects from previous cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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 (ORR)

Secondary study objectives

2-year Overall Survival (OS)

2-year Progression-Free Survival (PFS) Rate

6-month Best Response Rate

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Safety Lead-In EpcoritamabExperimental Treatment1 Intervention

Participants will be enrolled using a modified 3+3 dose-escalation design to establish the Recommended Phase 2 Dose of Epcoritamab and will complete study procedures as follows: * Baseline visit with CT scan and bone marrow biopsy. * Bone marrow biopsy before cycle 6. * Cycles 1 - 3: --Days 1, 8, 15, and 22 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * Cycles 4 - 9: --Days 1 and 15 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * Cycles 10 - 12: --Day 1 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * End of Treatment visit with CT scan and bone marrow biopsy. * Follow up visits: every 3 months for 2 years * Off study visit * If there are 0 out of 3 dose-limiting toxicities (DLTs), the study will proceed to phase II. If 1/3 participants experience a DLT, up to 3 additional participants will be treated at the same dose level. If more than 1/6 total participants experience a DLT, then the study will not proceed to phase 2.

Group II: Phase II EpcoritamabExperimental Treatment1 Intervention

Participants will be enrolled and will complete study procedures as follows: * Baseline visit with CT scan and bone marrow biopsy. * Bone marrow biopsy before cycle 6. * Cycles 1 - 3: --Days 1, 8, 15, and 22 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * Cycles 4 - 9: --Days 1 and 15 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * Cycles 10 - 12: --Day 1 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily. * End of Treatment visit with CT scan and bone marrow biopsy. * Follow up visits: every 3 months for 2 years * Off study visit

0 / 14Eligibility criteria met