Polatuzumab Vedotin Combo for Lymphoma

(POLARGO Trial)

Recruiting at 114 trial locations

Overseen By MO40598 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: Immunotherapy, Immunosuppressive therapy

Disqualifiers: Severe allergies, CNS lymphoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

270 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with relapsed or refractory diffuse large B-cell lymphoma who have had at least one prior therapy. They should not be planning a stem cell transplant, must agree to use contraception if of childbearing potential, and cannot have severe allergies to monoclonal antibodies or certain chemotherapy drugs.

Inclusion Criteria

My blood counts are within a healthy range.

I agree to not have sex or use birth control and not donate sperm.

I have had treatment for transformed lymphoma or received anthracycline for indolent lymphoma.

Exclusion Criteria

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products

I have not received a live vaccine in the last 4 weeks.

I haven't had major surgery in the last 6 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-in

Safety of polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin is assessed in 10 participants

Up to 8 cycles (21 days per cycle)

Randomized Controlled Trial (RCT)

Comparison of Pola-R-GemOx versus R-GemOx alone using overall survival as the primary endpoint

Up to 8 cycles (21 days per cycle)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 49 months

Treatment Details

Interventions

• Gemcitabine
• Oxaliplatin
• Polatuzumab Vedotin
• Rituximab

Trial Overview The study tests the safety and effectiveness of Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (R-GemOx) against R-GemOx alone in patients whose lymphoma has returned after treatment or did not respond well to previous therapies.

Participant Groups

Group I: Pola-R-GemOx (Stage 2) Experimental Treatment 4 Interventions

Participants will receive polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle administered IV and rituximab 375 mg/m\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.

Group II: Pola-R-GemOx (Stage 1) Experimental Treatment 4 Interventions

Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) for a maximum dose of 240 mg per cycle (mg/cycle) administered intravenously (IV) and rituximab 375 milligrams per square meter (mg/m\^2) administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.

Group III: R-GemOx (Stage 2) Active Control 3 Interventions

Participants will receive rituximab 375 mg/m\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University