Epcoritamab in Previously Treated WM
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGottfried von Keudell, MD PhD
About this trial
This study is being done to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia (WM).
The names of the study drug involved in this study is:
-Epcoritamab (a type of antibody)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A diagnosis of lymphoplasmacytic lymphoma/WM that is CD20+ by immunophenotype or immunohistochemistry confirmed by bone marrow biopsy/aspirate (fresh or archival tissue acceptable) at time of most recent progression. All degrees of CD20 positivity will be accepted.
Serum IgM level >2x upper limit of normal (ULN)
Meeting criteria for initiation of treatment per IWWM2 criteria [Kyle Semin Oncol 2002], including but not limited to hyperviscosity syndrome, peripheral neuropathy, cold agglutinin disease, cryoglobulinemia, amyloidosis, cytopenias due to bone marrow infiltration, symptomatic or bulky lymph nodes, symptomatic splenomegaly, constitutional symptoms not otherwise explained by other causes, signs of organ dysfunction secondary to WM
At least one prior line of treatment that was discontinued either due to intolerance or disease progression
Disqualifiers
Participants who have disease that has transformed to aggressive lymphoma
Participants with symptomatic or suspected hyperviscosity syndrome or IgM levels greater than 4000 mg/dL who are unable to undergo plasmapheresis to decrease the risk of an IgM flare. Participants who can undergo plasmapheresis will be eligible as long as they undergo the procedure prior to first treatment dose.
Participants who are receiving any other investigational agent
Washout from prior therapy: BTKi: no less than5 half-lives prior to epcoritamab to prevent BTKi rebound and rituximab: no less than 4 weeks (28 days) from last dose.
Trial design
Design model
Sequential
Treatments tested in this trial
Epcoritamab
DrugBispecific antibody, via subcutaneous (under the skin) injection per protocol.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Safety Lead-In EpcoritamabExperimental treatment 1 intervention
Group B: Phase II EpcoritamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response Rate (ORR)
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on modified IWWM6 criteria.
Time frame
Up to 12 cycles of treatment (28 days per cycle)Secondary outcomes
1
6-month Best Response Rate
Best response on treatment was based on modified IWWM6 criteria. Including complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and progressive disease (PD). Rate defined as the proportion of participants achieving the certain response.
Time frame
6 months2
Major Response Rate (MRR)
MMR defined as proportion pf participants achieving the major response includes PR, VGPR, and CR based on IWWM6 criteria.
Time frame
Up to 12 cycles of treatment (28 days per cycle)3
Median Time to Best Response
Best response on treatment was based on modified IWWM6 criteria. Time to event outcome estimate using Kaplan-Meier method.
Time frame
Up to 12 cycles of treatment (28 days per cycle)4
Median Duration of Overall Response (DOR)
Duration of Overall Response (DOR), estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) per modified IWWM6 criteria, until the first date that recurrent or progressive disease is objectively documented. Participants without progressive disease are censored at the date of last disease assessment.
Time frame
Up to 12 cycles of treatment (28 days per cycle)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gottfried von Keudell, MD PhD
Lead sponsor
Beth Israel Deaconess Medical Center
Sponsor institution
Genmab
Collaborator
Source ClinicalTrials.gov