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: A Prospective, Multicenter, Single-Arm Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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∙ \-

∙ Participants must meet all of the following criteria to participate in the study:

• Age ≥18 years old;

• ineligible for autologous transplantation;

• Sign the Informed Consent Form (ICF);

• CD79b-positive DLBCL confirmed by pathology (including transformed DLBCL, PMBL, HGBCL);

• Patients must have received adequate first-line treatment and only first-line treatment, with

‣ Anti-CD20 monoclonal antibodies (unless the investigator determines that the tumor is CD20-negative)

⁃ Chemotherapy regimens containing anthracyclines

• Recurrent or refractory diseases after first-line immunochemotherapy:

‣ Refractory disease is defined as not having a complete response to first-line therapy (except for patients who are intolerant to first-line therapy)

⁃ Recurrent disease is defined as disease recurrence after complete response to first-line treatment

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, with an expected survival of more than 12 weeks.

• Have at least one measurable two-dimensional lesion identified by clinical examination, CT scan or MRI: ① lymph node \>1.5cm; ② Other non-lymph node lesions ≥1.0cm;

• The main tissues and organs function well:

∙ Hematological function: absolute granulocyte count ≥ 1,000/mm3, platelet count ≥ 75,000/mm3; Liver function: ALT/AST \< 3 times upper limit of normal (ULN) and total bilirubin ≤1.5× upper limit of normal (ULN) (\< 5 times ULN in patients with Gilbert syndrome, cholestasis due to hilar compression adenopathy, biliary obstruction due to liver involvement or lymphoma); Renal function: creatinine clearance \> 30 mL/min, creatinine ≤1.5× upper limit of normal (ULN) Lung function: indoor oxygen saturation ≥95%; Cardiac function: no obvious cardiac insufficiency or cardiovascular disease; 10. Fertile patients must be willing to use highly effective contraception during the study period and for 120 days after the last dose of treatment.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Wenhao Zhang, M.D
ZWHL98@foxmail.com
021-64175590
Time Frame
Start Date: 2025-05-08
Estimated Completion Date: 2027-11-15
Participants
Target number of participants: 130
Treatments
Experimental: Treatment group
Second-line salvage therapy for relapsed/refractory DLBCL patients ineligible for autologous transplantation.
Sponsors
Leads: Fudan University
Collaborators: Fujian Cancer Hospital

This content was sourced from clinicaltrials.gov