Relapsed/Refractory Diffuse Large B Cell Lymphoma
Conditions
Keywords
relapsed/refractory diffuse large B cell lymphoma, epcoritamab, GemOx, gemcitabine, oxaliplatin, autologous stem cell transplant
Brief summary
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.
Interventions
DRUGEpcoritamab
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)
Subjects will receive gemcitabine 1000 mg/m2 on days 1 and 15 of the three 21-day cycles.
DRUGOxaliplatin
Subjects will receive oxaliplatin 100 mg/m2 on day 1 of three 21-day cycles.
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine ORR and CR after GemOx plus low-dose Epcoritamab | From enrollment to the end of treatment at 14 weeks | Determine ORR and CR after 3 cycles of GemOx plus low-dose Epcoritamab based on PET-CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Establish feasibility | From enrollment up to day 29 | Determine the number of subjects that complete the first cycle without need for hospitalization |
| Describe cytokine release syndrome incidence | From day 1 up to day 29 | Describe the number of subjects who develop grade 2-4 cytokine release syndrome during the first cycle of treatment |
| Describe immune effector cell- associated neurotoxicity syndrome incidence | From day 1 up to week 10 | Describe the number of subjects that develop immune effector cell-associated neurotoxicity syndrome |
| Describe adverse events | From day 1 up to week 10 | Describe the number of subjects that develop any adverse events |
| Determine number of patients that follow through with transplant | From day one up through study completion, an average of 1 year | Determine the number of patients that go through with stem cell transplant after finishing 3 cycles of Epcoritamab + GemOx |
| Duration of response | From week 18 through study completion, an average of 1 year | Determine the duration of response |
| Progression free survival | From week 18 up to six and twelve months | Report the subjects´ progression free survival |
| Overall survival | From day 1 to twelve months | Report the overall survival |
Countries
Mexico
Contacts
CONTACTPerla R Colunga-Pedraza, MD
CONTACTNatalia Huergo-Treviño, MD
PRINCIPAL_INVESTIGATORPerla R Colunga-Pedraza, MD
Hospital Universitario "Dr. José Eleuterio González"
Outcome results
None listed