Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT05498220
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab vedotin (PV) — DRUG
    1.8 mg/kg, intravenous, at day 1, in every 21 days
  • Rituximab — DRUG
    375 mg/m2 intravenous, at day 1 or day 2, in every 21 days
  • Hyaluronidase — DRUG
    1,400 mg/23,400 units sub-cutaneous, starts at cycle 2, in every 21 days
  • Gemcitabine — DRUG
    1,000 mg/m2 intravenous at day 1 and 8, in every 21 days
  • Cisplatin — DRUG
    75 mg/m2, intravenous, at day 1, in every 21 days
  • Dexamethasone — DRUG
    40 mg intravenous at day 1, Per oral days at days 2-4
  • GCSF — DRUG
    granulocyte-colony stimulating factor (GCSF )

Study Details

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.

Key Dates

Start date
Feb 17, 2023
Status verified
Mar 2026
Primary completion
Mar 7, 2025
Completion
Oct 3, 2025

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    The subjects with diffuse large B-cell lymphoma were relapsed or refractory after the first treatment and receiving the study protocol treatment.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 4 months (End of Treatment) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514-

Find similar trials in Chapel Hill, NC

By research site
Lineberger Comprehensive Cancer Center· Chapel Hill, NC

Related Studies