Glofitamab + Polatuzumab-R-CHP for Diffuse Large B-Cell Lymphoma
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Philippe Armand, MD, PhD
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial tests a combination of drugs to treat high-risk diffuse large B-cell lymphoma in patients who have not been treated before. The drugs help the immune system attack cancer and directly kill cancer cells. The standard treatment for diffuse large B-cell lymphoma (DLBCL) includes rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
Eligibility Criteria
This trial is for adults over 18 with untreated high-risk diffuse large B-cell lymphoma (DLBCL), a type of cancer. They must have an IPI score of 2-5, be in decent physical shape (ECOG 0-1-2), and their heart and other organs must work well. Women who can have babies and men must agree to use birth control. People with prior organ transplants, recent cancer treatments, or certain infections like HIV can't join.Treatment Details
The study tests Glofitamab combined with Polatuzumab alongside standard chemo R-CHP (Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Prednisone) for treating DLBCL. Glofitamab is a T-cell bispecific antibody; Polatuzumab is an antibody-drug conjugate; R-CHP are established chemotherapy drugs.
1Treatment groups
Experimental Treatment
Group I: Polatuzumab + Glofitamab + R-CHExperimental Treatment6 Interventions
-Participants will receive treatment interventions as outlined: Experimental: Safety Lead-In Phase of 6 Participants, Total Enrollment of 40 Participants
* Polatuzumab, once, predetermined day and dosage per cycle, per protocol Cycles 1 - 6
* R-CHP (Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Prednisone
* Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride once, predetermined day and dosage per cycle, per protocol Cycles 1 - 6:
* Prednisone) 5 days, predetermined day and dosage per cycle, per protocol Cycles 1 - 6:
* Glofitamab
* twice, predetermined day and dosage per cycle, per protocol Cycle 3-6
* once, predetermined day and dosage per cycle, per protocol Cycle 7-8
* Participants who need urgent therapy are also allowed to proceed with one cycle of R-CHOP for 1 cycle per standard of care.
* Participants will be followed for up to 5 years post-treatment.
Glofitamab is already approved in United States for the following indications:
🇺🇸 Approved in United States as COLUMVI for:
- Relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL), or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy
Find a clinic near you
Research locations nearbySelect from list below to view details:
Beth Israel Deaconess Medical CenterBoston, MA
Brigham and Women's HospitalBoston, MA
University of Miami Sylvester Cancer CenterMiami, FL
Dana Farber Cancer InstituteBoston, MA
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Who is running the clinical trial?
Philippe Armand, MD, PhDLead Sponsor
Jennifer Crombie, MDLead Sponsor
Genentech, Inc.Industry Sponsor