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Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma
Sponsor: UNC Lineberger Comprehensive Cancer Center
Summary
This study aimed to evaluate the efficacy of a novel regimen consisting of polatuzumab vedotin in combination with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP) for the treatment of diffuse large B-cell lymphoma that either came back or did not improve after the treatments (rrDLBCL). This combination has not been approved by the Food and Drug Administration (FDA) for the treatment of rrDLBCL. Salvage therapy (treatment after standard treatment failed) needs to be improved. Rituximab, gemcitabine, dexamethasone, and cisplatin combination is a standard therapy for rrDLBCL and polatuzumab vedotin (PV) is a novel antibody-drug conjugate targeting CD79b. PV has shown efficacy in the setting of rrDLBCL and can improve the response rates of standard salvage therapy. This study will focus on subjects in the first relapse (one prior regimen) and will include both subjects who are transplant eligible and those who are transplant ineligible.
Official title: A Phase II Trial Evaluating the Efficacy of Polatuzumab Vedotin With Rituximab, Gemcitabine, Dexamethasone, and Cisplatin (PV-RGDP) Chemotherapy for Relapsed or Refractory Diffuse Large B-cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2023-02-17
Completion Date
2026-11-07
Last Updated
2025-09-02
Healthy Volunteers
No
Conditions
Interventions
Polatuzumab vedotin (PV)
1.8 mg/kg, intravenous, at day 1, in every 21 days
Rituximab
375 mg/m2 intravenous, at day 1 or day 2, in every 21 days
Hyaluronidase
1,400 mg/23,400 units sub-cutaneous, starts at cycle 2, in every 21 days
Gemcitabine
1,000 mg/m2 intravenous at day 1 and 8, in every 21 days
Cisplatin
75 mg/m2, intravenous, at day 1, in every 21 days
Dexamethasone
40 mg intravenous at day 1, Per oral days at days 2-4
GCSF
granulocyte-colony stimulating factor (GCSF )
Locations (1)
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States