Epcoritamab in Previously Treated WM
NCT Number: NCT06510491
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Waldenstrom Macroglobulinemia|B-Cell Lymphoproliferative Disorder
Interventions: DRUG: Epcoritamab
Sponsor: Gottfried von Keudell, MD PhD
Collaborators: Genmab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-12-31
Locations: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
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)

Primary Outcome Measures: 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., Up to 12 cycles of treatment (28 days per cycle)
Secondary Outcome Measures: 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., 6 months|Major Response Rate (MRR), MMR defined as proportion pf participants achieving the major response includes PR, VGPR, and CR based on IWWM6 criteria., Up to 12 cycles of treatment (28 days per cycle)|Median Time to Best Response, Best response on treatment was based on modified IWWM6 criteria. Time to event outcome estimate using Kaplan-Meier method., Up to 12 cycles of treatment (28 days per cycle)|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., Up to 12 cycles of treatment (28 days per cycle)|2-year Progression-Free Survival (PFS) Rate, 2-year PFS is a probability estimated using progression-free survival based on the Kaplan-Meier method is defined as the duration between registration and documented disease progression (PD) or death, or is censored at time of last disease assessment., 2 years|Median Time to Next Line of Therapy (TTNT), Kaplan-Meir method will be used to estimate the TTNT. TTNT is defined as period of time from initiation of epcoritamab until start of next line of treatment., Up to 2 years|2-year Overall Survival (OS), 2-year OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive., 2 years|Grade 3-5 Treatment-related Toxicity Rate, All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on IWWM6 criteria that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation., Up to 12 cycles of treatment (28 days per cycle)