Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma

Best response of complete response (CR) rate

The combination of epcoritamab-lenalidomide in chemotherapy ineligible patients with primary refractory or relapsed immunodeficiency-related large B-cell lymphoma, indicated by the number of patients with CR as best response (using the Lugano Criteria) divided by the total number of patients who have received 1 dose of combination therapy and have had response assessment by radiographic imaging by 6 months from start of therapy. The six-month best response of CR rate will be estimated by the number of patients with complete response divided by the total number of patients who have received 1 dose of combination therapy and have had response assessment by radiographic imaging by 6 months from start of therapy. This estimation will be compared with the historical control 35% by Exact Test of one proportion. At the same time, the Blyth-Still-Casella exact binomial 95% confidence interval of this CR rate will be calculated with adjustment.

Objective response rate (ORR)

The ORR will be estimated by calculating the proportion of treated subjects who experience an objective response (confirmed CR or confirmed partial response \[PR\] per Lugano Criteria) among all evaluable patients. ORR data will be collected from the initiation of trial therapy (cycle \[C\] 1 day \[D\] 1) until: the response has been confirmed, the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation (whichever occurs first). The ORR, PR and CR rates for patients on combination epcoritamab-lenalidomide, as well as their corresponding Blyth-Still-Casella exact binomial 95% confidence intervals, will be estimated for each time point at 3, 6, 12, 18 and 24 months.

Duration of response (DOR)

The DOR for combination epcoritamab-lenalidomide is defined as the elapses between the day of first documented response to trial therapy (CR or PR, whichever is recorded firstly) and subsequent disease progression (taking as reference for progressive disease the smallest tumor measurements recorded on study per Lugano Criteria), with possible censored at 6, 12, 18, or 24 months for different analysis. By the setting of multiple check and censor time points, the data will be released from cancer center as early as 6 months, which is a routine setting for cellular therapies For DOR analysis, response is defined as CR or PR per the 2014 Lugano Criteria; and disease progression is defined as progressive disease (PD) per the 2014 Lugano Criteria. The median of DOR censored at 6, 12, 18 and 24 months for patients on combination epcoritamab-lenalidomide will be estimated with 95% confidence interval. In addition, the DoRs at different time points will be descrived by Kaplan-Meier curve.

Progression-free survival (PFS)

PFS data will be collected from initiation of trial therapy (C1D1) until the subject suffers disease progression, initiates subsequent anti-cancer therapy due to disease progression on study regimen, completes study participation, or experiences death from any cause (whichever is sooner). If disease progression or death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the PFS will be censored at 12, 18 or 24 months during follow-up. The median of PFS with 12, 18, and 24 months of follow-up for patients on combination epcoritamab-lenalidomide, and corresponding 95% confidence interval, will be estimated. And the Kaplan-Meier curve will be employed again to visualize PFS.

Overall survival (OS)

OS data will be collected from initiation of trial therapy (C1D1) until the patient completes study follow up participation, experiences death from any cause or is documented as lost to follow up per institutional standard (whichever is sooner). If death from any cause is not observed prior to completing study participation, the OS will be censored as the time of the last available documentation of survival status. The median of OS with 12, 18, and 24 months of follow-up for patients on combination epcoritamab-lenalidomide, and corresponding 95% confidence interval, will be estimated. And the Kaplan-Meier curve will be employed again to visualize OS.