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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epcoritamab + GemOx | Experimental | Subjects will receive Gemcitabine/Oxaliplatin at usual doses as well as Epcoritamab with 2 step up doses followed by 12 mg weekly for 3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epcoritamab | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Establish feasibility | Determine the number of subjects that complete the first cycle without need for hospitalization | From enrollment up to day 29 |
| Describe cytokine release syndrome incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Perla R Colunga-Pedraza, MD | Contact | +52 8110761973 | alrep_rcp@gmail.com | |
| Natalia Huergo-Treviño, MD | Contact | +524442416594 | nat.hue94@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Perla R Colunga-Pedraza, MD | Hospital Universitario "Dr. José Eleuterio González" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario "Dr. José Eleuterio González" | Recruiting | Monterrey | Nuevo León | 64640 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34508654 | Background | Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8. | |
| 39935086 |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine (1000 mg/m2) | Drug | Subjects will receive gemcitabine 1000 mg/m2 on days 1 and 15 of the three 21-day cycles. |
|
| Oxaliplatin | Drug | Subjects will receive oxaliplatin 100 mg/m2 on day 1 of three 21-day cycles. |
|
Describe the number of subjects who develop grade 2-4 cytokine release syndrome during the first cycle of treatment
| 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 | From day 1 up to week 10 |
| Describe adverse events | Describe the number of subjects that develop any adverse events | 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 | From day one up through study completion, an average of 1 year |
| Duration of response | Determine the duration of response | From week 18 through study completion, an average of 1 year |
| Progression free survival | Report the subjects´ progression free survival | From week 18 up to six and twelve months |
| Overall survival | Report the overall survival | From day 1 to twelve months |
| Background |
| Li T, Gibiansky L, Parikh A, Putnins M, Chiu CW, Sacchi M, Feng H, Ahmadi T, Gupta M, Xu S. Optimal Dosing Regimen for Epcoritamab, a Subcutaneous Bispecific Antibody, in Relapsed or Refractory Large B-Cell Lymphoma. Clin Pharmacol Ther. 2025 May;117(5):1437-1450. doi: 10.1002/cpt.3588. Epub 2025 Feb 11. |
| 39322711 | Background | Thieblemont C, Karimi YH, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Jurczak W, Do YR, Gasiorowski R, Lewis DJ, Kim TM, van der Poel M, Poon ML, Feldman T, Linton KM, Sureda A, Hutchings M, Dinh MH, Kilavuz N, Soong D, Mark T, Sacchi M, Phillips T, Lugtenburg PJ. Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial. Leukemia. 2024 Dec;38(12):2653-2662. doi: 10.1038/s41375-024-02410-8. Epub 2024 Sep 25. |
| 37921363 | Background | Izutsu K, Kumode T, Yuda J, Nagai H, Mishima Y, Suehiro Y, Yamamoto K, Fujisaki T, Ishitsuka K, Ishizawa K, Ikezoe T, Nishikori M, Akahane D, Fujita J, Dinh M, Soong D, Noguchi H, Buchbjerg JK, Favaro E, Fukuhara N. Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B-cell lymphoma. Cancer Sci. 2023 Dec;114(12):4643-4653. doi: 10.1111/cas.15996. Epub 2023 Nov 3. |
| 39792928 | Background | Brody JD, Jorgensen J, Belada D, Costello R, Trneny M, Vitolo U, Lewis DJ, Karimi YH, Sureda A, Andre M, Wahlin BE, Lugtenburg PJ, Jiang T, Karagoz K, Steele AJ, Abbas A, Wang L, Risum M, Cordoba R. Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial. Blood. 2025 Apr 10;145(15):1621-1631. doi: 10.1182/blood.2024026830. |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |