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The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R/R DLBCL | Experimental | Participants will receive up to 3 21-day cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glofitamab | Drug | Participants will receive intravenous (IV) glofitamab for up to 3 cycles. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR), defined as the proportion of participants that achieves a CR or PR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria | Up to 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) after enrollment | From enrollment to the first occurrence of disease progression, initiation of new anti-lymphoma therapy (not including planned ASCT or CAR-T therapy), or death from any cause (whichever occurs first) (up to 2.5 years) | |
| Progression-free survival (PFS) after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center UCI | Orange | California | 92868 | United States | ||
| Memorial Cancer Institute at Memorial West |
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| Obinutuzumab |
| Drug |
Participants will receive IV obinutuzumab on Cycle 1 Day 1. |
|
| Tocilizumab | Drug | Participants will receive IV tocilizumab as necessary to manage cytokine release syndrome (CRS) events. |
|
| Rituximab | Drug | Participants will receive up to 2 doses of IV rituximab. |
|
| Ifosfamide | Drug | Participants will receive IV ifosfamide for up to 3 cycles. |
|
| Carboplatin | Drug | Participants will receive IV carboplatin for up to 3 cycles. |
|
| Etoposide | Drug | Participants will receive IV etoposide for up to 3 cycles. |
|
| From enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years) |
| Mobilization-adjusted response rate (MARR) | The proportion of participants treated with intent to proceed to ASCT that achieves a CR or PR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria, and additionally achieves mobilization of a minimum of 2,000,000 CD34+ hematopoietic stem cells/kg for ASCT | Up to 2.5 years |
| Overall survival (OS) after enrollment | From enrollment to death from any cause (up to 2.5 years) |
| CR rate after enrollment, defined as the proportion of participants that achieves a CR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria | Up to 2.5 years |
| Duration of Response (DOR) | From the first occurrence of a documented objective response (CR or PR) to disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years) |
| Duration of complete response (DOCR) | From the first occurrence of a documented complete response to disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years) |
| Percentage of participants with adverse events (AEs) | Up to 2.5 years |
| Percentage of participants with cytokine release syndrome (CRS) | Up to 2.5 years |
| Maximum serum concentration (Cmax) of glofitamab | Up to 2.5 years |
| Minimum serum concentration (Cmin) of glofitamab | Up to 2.5 years |
| Percentage of participants with anti-drug antibodies (ADAs) | From baseline up to 2.5 years |
| Pembroke Pines |
| Florida |
| 33028 |
| United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 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 |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000720108 | glofitamab |
| C543332 | obinutuzumab |
| C502936 | tocilizumab |
| D000069283 | Rituximab |
| D007069 | Ifosfamide |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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