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

NCT ID: NCT07001540

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2027-11-15

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.

Detailed Description

This prospective, multicenter, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of Pola-R-GemOx in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are unsuitable for autologous transplantation. The study aims to enroll 130 patients, all of whom will initially receive three cycles of Pola-R-GemOx. Subsequent treatment decisions will be based on therapeutic efficacy and transplant assessment. ① Patients achieving complete response (CR) or partial response (PR) after three cycles will proceed with an additional three cycles. Those achieving CR following six cycles will conclude treatment, while all other patients will transition to subsequent-line therapy. ② Patients who do not achieve CR or PR after three cycles will discontinue the regimen and proceed directly to subsequent-line therapy. The primary endpoint of the trial is the investigator-assessed objective response rate (ORR). Secondary endpoints include other efficacy measures, such as complete response rate (CR), event-free survival (EFS), 24-month progression-free survival (PFS) rate, overall survival (OS), and safety outcomes. Additionally, exploratory analyses will be conducted to identify potential predictors of clinical efficacy and safety.

Conditions

Diffuse Large B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

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

1. Age ≥18 years old;

2. ineligible for autologous transplantation;

3. Sign the Informed Consent Form (ICF);

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

5. 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

6. 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

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

8. 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;

9. 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.

Exclusion Criteria

-

Subjects who meet any of the following criteria are not eligible to participate in this study:

1. 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.

2. Known human immunodeficiency virus (HIV) infection or immunoassay positive；

3. 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)

4. 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);

5. Patients who have previously received oxaliplatin or gemcitabine treatment;

6. Pregnant or lactating patients;

7. Other concurrent serious illness or medical condition that would prevent participation in the study;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Rong Tao

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenhao Zhang, M.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenhao Zhang, M.D

Role: CONTACT

ZWHL98@foxmail.com

021-64175590

Facility Contacts

Wenhao Zhang, M.D

Role: primary

ZWHL98@foxmail.com

021-64175590

Other Identifiers

Pola-R-Gemox

Identifier Type: -

Identifier Source: org_study_id