Pola‑R‑GemOx chemotherapy for relapsed/refractory DLBCL in patients who cannot have an autologous transplant

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

This trial will test whether adding polatuzumab vedotin to rituximab, gemcitabine, and oxaliplatin helps people with relapsed or refractory DLBCL who are not eligible for autologous stem‑cell transplant.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: Chemotherapy, Polatuzumab, Rituximab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07001540 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, single‑arm Phase II study enrolling about 130 patients with CD79b‑positive relapsed or refractory DLBCL who are ineligible for autologous transplantation. All participants receive three cycles of polatuzumab vedotin combined with rituximab, gemcitabine, and oxaliplatin (Pola‑R‑GemOx); responders (CR or PR) receive three additional cycles while nonresponders move to next‑line therapy. The primary endpoint is investigator‑assessed objective response rate (ORR), with secondary endpoints including complete response rate, event‑free survival, 24‑month progression‑free survival rate, overall survival, and safety. Exploratory analyses will look for biomarkers or clinical factors that predict response and tolerability.

Who should consider this trial

Good fit: Adults (≥18 years) with CD79b‑positive relapsed or refractory DLBCL who have received standard first‑line immunochemotherapy, are ineligible for autologous transplantation, and have ECOG performance status 0–2 are the intended participants.

Not a fit: Patients who are CD79b‑negative, who have received multiple prior lines beyond first‑line therapy, who are eligible for autologous transplant, or who have poor performance status or significant comorbidities may not benefit from this regimen.

Why it matters

Potential benefit: If successful, this regimen could provide an effective salvage option that increases response rates and disease control for transplant‑ineligible patients with relapsed/refractory DLBCL.

How similar studies have performed: Polatuzumab vedotin combinations have shown clinical activity in relapsed DLBCL and supported regulatory approvals in other combinations, though the specific Pola‑R‑GemOx salvage approach is less extensively tested.

Eligibility criteria

Inclusion Criteria:

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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:

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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;

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Wenhao Zhang, M.D — Fudan University
• Study coordinator: Wenhao Zhang, M.D

Conditions: Diffuse Large B-Cell Lymphoma, Polatuzumab vedotin combined with rituximab, gemcitabine and oxaliplatin, Recurrent/refractory diffuse large B-cell lymphoma that is not suitable for autologous migration, Prospective, multicenter, single-armed