Low Dose Epcoritamab Plus GemOx in R/R DLBCL

Phase 2RecruitingNCT07451652

Hospital Universitario Dr. Jose E. Gonzalez10 enrolled

Overview

In this study, researchers are looking to determine whether Gemcitabine/Oxaliplatin plus a lower dose of Epcoritamab (12 mg) works to treat subjects with relapsed/refractory diffuse large B-cell lymphoma, who are candidates to autologous stem cell transplantation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Relapsed/Refractory Diffuse Large B Cell Lymphoma

Interventions

EpcoritamabDRUG

Subjects will receive 2 step up doses of Epcoritamab (0.16 mg and 0.8 mg) followed by 12 mg weekly, for a total of three 21-day cycles (8 applications)

Gemcitabine (1000 mg/m2)DRUG

Subjects will receive gemcitabine 1000 mg/m2 on days 1 and 15 of the three 21-day cycles.

OxaliplatinDRUG

Subjects will receive oxaliplatin 100 mg/m2 on day 1 of three 21-day cycles.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with relapsed/refractory diffuse large B-cell lymphoma who have received at least 1 previous line of treatment and that are candidates to autologous stem cell transplant * ECOG 0-2 * Women of reproductive age who agree on getting a contraceptive method * Subjects who fulfill Lugano´s criteria for disease activity * Subjects who voluntarily accept to participate in this study Exclusion Criteria: * Active bacterial, viral or fungal infection * Subjects who have already received an autologous o allogeneic stem cell transplantation * Subjects with other active neoplasias * Subjects with end-stage failure

Locations (1)

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, Mexico

RECRUITING

Outcomes

Primary Outcomes

Determine ORR and CR after GemOx plus low-dose Epcoritamab

Determine ORR and CR after 3 cycles of GemOx plus low-dose Epcoritamab based on PET-CT

Time frame: From enrollment to the end of treatment at 14 weeks

Secondary Outcomes

Establish feasibility

Determine the number of subjects that complete the first cycle without need for hospitalization

Time frame: From enrollment up to day 29

Describe cytokine release syndrome incidence

Describe the number of subjects who develop grade 2-4 cytokine release syndrome during the first cycle of treatment

Time frame: From day 1 up to day 29

Describe immune effector cell- associated neurotoxicity syndrome incidence

Describe the number of subjects that develop immune effector cell-associated neurotoxicity syndrome

Time frame: From day 1 up to week 10

Describe adverse events

Describe the number of subjects that develop any adverse events

Time frame: From day 1 up to week 10

Determine number of patients that follow through with transplant

Determine the number of patients that go through with stem cell transplant after finishing 3 cycles of Epcoritamab + GemOx

Time frame: From day one up through study completion, an average of 1 year

Duration of response

Determine the duration of response

Time frame: From week 18 through study completion, an average of 1 year

Central Contacts

Perla R Colunga-Pedraza, MD

CONTACT

+52 8110761973 alrep_rcp@gmail.com

Natalia Huergo-Treviño, MD

CONTACT

+524442416594 nat.hue94@gmail.com

Data from ClinicalTrials.gov

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