REBEL: A Phase 1b Study on the Safety and Feasibility of External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed/Refractory DLBCL
Summary
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.
Arms & interventions
- DrugEpcoritamab
Epcoritamab will be administered per standard of care.
- DrugGlofitamab
Glofitamab will be administered per standard of care.
- RadiationExternal Beam Radiation Therapy
Participants will receive radiation therapy for 5 fractions completed on sequential days.
Outcome measures
Primary
The 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
Secondary
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
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.
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.
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.
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.
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.
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.
Time frame: 18 months
Eligibility criteria
Study locations (1)
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112