A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
Jennifer Crombie, MD
Summary
The goal of this research study is to evaluate the combination of study drugs, Glofitamab and Polatuzumab, and a standard chemotherapy regimen, R-CHP, as a treatment for high-risk diffuse large B-cell lymphoma. The names of the treatment interventions involved in this study are: * Glofitamab (T-cell bispecific antibody) * Polatuzumab (antibody-drug conjugate) * R-CHP (a chemotherapy regimen comprised of Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, and Prednisone)
Description
This study is an open-label, multi-center, single-arm phase II study of glofitamab plus polatuzumab and R-CHP for patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL). * Study procedures include screening for eligibility, study evaluations, radiological scans of tumors, tumor biopsies, TTE/MUGA scans, and blood collections. * All participants will receive two cycles of polatuzumab -R-CHP and four cycles of glofitamab- polatuzumab -R-CHP. After completion of chemotherapy patients will receive two additional cycles of glofitamab alone. * Participants receive s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms * DLBCL, not otherwise specified (NOS) * T-cell/histiocyte-rich large B-cell lymphoma * Epstein-Barr virus-positive DLBCL, NOS * ALK-positive large B-cell lymphoma * HHV8-positive DLBCL, NOS * High-grade B-cell lymphoma (HGBCL), NOS * HGBCL with translocations of MYC and BCL-2, or MYC and BCL-6 * Availability of archival (within 90 days) or freshly collected tumor tissue before study enrollment. If archival tissu…
Interventions
- DrugGlofitamab
human IgG1-bispecific antibody, via IV infusion
- DrugPolatuzumab
an antibody drug conjugate (ADC) that contains a humanized IgG1 anti-human CD79b monoclonal antibody, via IV infusion
- DrugRituximab
Per standard care, via IV infusion
- DrugDoxorubicin Hydrochloride
Per standard care, via IV infusion
- DrugCyclophosphamide
Per standard care, via IV infusion
- DrugPrednisone
Per standard care, orally
Locations (3)
- University of Miami Sylvester Cancer CenterMiami, Florida
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts