Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-01 @ 7:57 PM
Study NCT ID:
NCT05800366
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-14
First Post:
2023-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
Sponsor:
Jennifer Crombie, MD
Organization:
Study Overview
Official Title:
A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
Detailed 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 study treatment for up to 8 cycles of treatment and will be followed for 5 years.
* It is expected that about 40 people will take part in this research study.
* This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
* The U.S. Food and Drug Administration (FDA) has not approved glofitamab as a treatment for any disease.
* The FDA has approved polatuzumab in combination with rituximab and another chemotherapy agent, bendamustine, for DLBCL that has already been treated with two prior treatments, but not as an initial therapy.
* The R-CHP regimen is FDA approved and standard care for cancer treatment.
* Genentech is supporting this research study by providing drug and funding for this trial.
* 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 study treatment for up to 8 cycles of treatment and will be followed for 5 years.
* It is expected that about 40 people will take part in this research study.
* This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
* The U.S. Food and Drug Administration (FDA) has not approved glofitamab as a treatment for any disease.
* The FDA has approved polatuzumab in combination with rituximab and another chemotherapy agent, bendamustine, for DLBCL that has already been treated with two prior treatments, but not as an initial therapy.
* The R-CHP regimen is FDA approved and standard care for cancer treatment.
* Genentech is supporting this research study by providing drug and funding for this trial.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: