Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation

Sponsor
Fudan University
Study ID
NCT07001540
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a prospective, multicenter, single-arm clinical study designed to evaluate the efficacy and safety of Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as salvage therapy for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) patients ineligible for autologous transplantation.

Key Dates

Start date
May 8, 2025
Status verified
Jun 2025
Primary completion
Nov 15, 2027
Completion
Nov 15, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Second-line salvage therapy for relapsed/refractory DLBCL patients ineligible for autologous transplantation.

Primary Outcome Measure

Invetigator-assessed Objective Response Rate (ORR) [ Time Frame: Assessed up to 3 years ]

Central Contacts

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