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

NCT07001540 | Recruiting Phase 2

• 1 other identifier: Pola-R-Gemox
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

Polatuzumab vedotin combined with rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx); Recurrent/refractory diffuse large B-cell lymphoma that is not suitable for autologous migration; Prospective, multicenter, single-armed

Outcome Measures

Primary Outcomes (1)

• Invetigator-assessed Objective Response Rate (ORR)

  Defined as the proportion of all analyzable subjects achieving complete response (CR) and partial response (PR) after study initiation.

  Assessed up to 3 years

Secondary Outcomes (5)

• The CR rate assessed by the investigator

  Assessed up to 3 years

• Event-free survival (EFS)

  Assessed up to 3 years

• 24-month progression-free survival (PFS) rate

  Assessed up to 24 months

• Overall survival time (OS)

  Assessed up to 15 years

• Security

  Assessed up to 3 years

Study Arms (1)

Treatment group

EXPERIMENTAL

Second-line salvage therapy for relapsed/refractory DLBCL patients ineligible for autologous transplantation.

Drug: Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx)

Interventions

Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx) DRUG

Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx)

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects who meet any of the following criteria are not eligible to participate in this study:
• Subjects with any factor that may affect their ability to comply with the protocol, as determined by the investigator, including uncontrollable medical, psychological, family, social, or geographical conditions, or those unwilling or unable to follow the procedures required by the study protocol.
• Known human immunodeficiency virus (HIV) infection or immunoassay positive；
• Viral infections that cannot be controlled by antiviral drugs, such as active herpes virus infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc. (Note: chronic HBV carriers or inactive HBsAg positive subjects with HBV-DNA lower than the lower limit of detection can be enrolled, requiring clinical evaluation and preventive antiviral therapy if appropriate; HCV antibody negative can be enrolled, HCV antibody positive patients need to test HCV-RNA, if negative can be enrolled)
• Patients with uncontrolled lymphomas with CNS infiltration (CNS disease diagnosed at initial diagnosis is allowed, provided complete remission of CNS disease is achieved and maintained and no CNS disease is present at recurrence);
• Patients who have previously received oxaliplatin or gemcitabine treatment;
• Pregnant or lactating patients;
• Other concurrent serious illness or medical condition that would prevent participation in the study;

Sponsors & Collaborators

• Fudan University: lead
• Fujian Cancer Hospital: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200231, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

Interventions

Rituximab; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Wenhao Zhang, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhao Zhang, M.D

CONTACT

021-64175590; ZWHL98@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)