The purpose of this clinical trial is to assess the safety and tolerability of ration therapy followed by receiving epcoritamab or glofitamab in patients with relapsed/refractory diffuse large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Epcoritamab will be administered per standard of care.
Glofitamab will be administered per standard of care.
Participants will receive radiation therapy for 5 fractions completed on sequential days.
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
RECRUITINGThe rate of CRS and ICANS adverse events as measured by ASTCT criteria attributed to RT and epcoritamab or glofitamab therapy.
To assess the safety and tolerability of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL. The study proposes this combination is safe and feasible if ≤20% of patients experience grade 3 or 4 cytokine release syndrome (CRS) (≤2 of 10 patients) and (2) ≤10% of patients experience grade 3 or 4 immune effector cell-associated neurotoxicity (ICANS) (≤1 of 10 patients).
Time frame: 18 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
Time frame: 18 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity as defined by the NIH CTCAE, version 6.0 and ASTCT.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
Time frame: 18 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness as defined by the NIH CTCAE, version 6.0 and ASTCT.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
Time frame: 18 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration as defined by the NIH CTCAE, version 6.0 and ASTCT.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
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Time frame: 18 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by the relationship to study treatment as defined by the NIH CTCAE, version 6.0 and ASTCT.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
Time frame: 18 months
Complete response rate (CRR), defined as the proportion of participants achieving a confirmed CR as defined by Lugano 2014 response criteria.
To assess the complete response rate (CRR) in the study population.
Time frame: 18 months
Objective response rate (ORR), defined as the proportion of participants achieving a confirmed PR and CR as defined by Lugano 2014 response criteria.
To assess the objective response rate (ORR) in the study population.
Time frame: 18 months