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A clinical trial to compare how well treatment with polatuzumab vedotin plus rituximab plus gemcitabine plus oxaliplatin (Pola-R-GemOx) works in people with diffuse large B-cell lymphoma versus treatment with R-GemOx alone
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Cancer
- Non-Hodgkin's Lymphoma
- Diffuse Large B-Cell Lymphoma (DLBCL)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Countries
- Brazil
- Canada
- China
- Finland
- France
- Germany
- Greece
- India
- Ireland
- Italy
- Mexico
- South Korea
- Spain
- Turkey
- Türkiye
- United Kingdom
- United States
Trial Identifier:
NCT04182204 2018-003727-10 MO40598
Trial Summary
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).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04182204,MO40598,2018-003727-10
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Why is the POLARGO clinical trial needed?
New treatments are needed for people who have a particular type of lymphoma called diffuse large B-cell lymphoma (DLBCL) that has not responded to, or has returned after, previous treatment. In previous clinical trials, standard lymphoma treatments have been shown to work better when given with a drug called polatuzumab vedotin. This trial will assess if a standard treatment called R-GemOx (which is rituximab plus gemcitabine plus oxaliplatin) works better when given with polatuzumab vedotin (all together referred to as Pola-R-GemOx), compared with R-GemOx alone.
How does the POLARGO clinical trial work?
This clinical trial is recruiting people who have a health condition called DLBCL. People can take part if they have:
- DLBCL that improved at first with treatment but has returned afterwards (known as relapsed DLBCL), or
- DLBCL that has not improved with treatment (known as refractory DLBCL)
The purpose of this clinical trial is to compare the effects, good or bad, of Pola-R-GemOx versus R-GemOx in people with DLBCL. People who take part in this clinical trial will receive either Pola-R-GemOx or R-GemOx.
Pola-R-GemOx treatment has been shown to have a good safety profile when assessed in a small number of people with DLBCL. This trial will now assess safety, and how well Pola-R-GemOx works, in a larger number of people with DLBCL.
What are the main endpoints of the POLARGO clinical trial?
The main clinical trial endpoints (the main results that are measured in the trial to see if the medicine has worked) are how long participants live (overall survival), and the safety of Pola-R-GemOx as measured by the number and type of side effects that participants experience.
The other clinical trial endpoints include:
- The percentage of participants who have no detectable cancer (complete response) at the end of treatment
- The percentage of patients who have either no detectable cancer or who have cancer that has reduced in size at the end of treatment (objective response rate)
- The time from the start of the trial to the first sign that the cancer has started to grow or spread (progression-free survival)
Who can take part in this clinical trial?
People can take part in this trial if they are at least 18 years of age and have been diagnosed with either relapsed or refractory DLBCL.
People may not be able to take part in this trial if they have certain medical conditions or have previously received certain treatments, including polatuzumab vedotin. Women cannot take part in this trial if they are pregnant or breastfeeding, or are planning to become pregnant soon after the clinical trial.
What treatment will participants be given in this clinical trial?
Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and will be given either:
- Pola-R-GemOx given as an infusion into the vein, every 3 weeks, for up to 6 months (eight rounds [also called ‘cycles’] of treatment), OR
- R-GemOx given as an infusion into the vein every 3 weeks, for up to 6 months (eight cycles of treatment)
For participants being given Pola-R-GemOx, the polatuzumab vedotin and rituximab infusions will be given on the same day, which will take 3–6 hours, and gemcitabine and oxaliplatin will be given on the following day over 2.5–6 hours.
For participants being given R-GemOx, the rituximab infusion will be given on one day and will take 1.5–4 hours, and gemcitabine and oxaliplatin will be given on the following day over 2.5–6 hours.
Participants will have an equal chance of being placed in either group.
Neither participants nor the clinical trial doctor can choose the group participants are in. However, the trial is open-label, which means that both participants and the clinical trial doctor will know which treatment participants have been given.
Are there any risks or benefits in taking part in this clinical trial?
The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to the participant, although it may not be greater than the risks related to routine medical care or the natural progression of the health condition. Potential participants will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. These will all be described in an informed consent document (a document that provides people with the information they need to make a decision to volunteer for a clinical trial). A potential participant should also discuss these with members of the research team and with their usual healthcare provider. Anyone interested in taking part in a clinical trial should know as much as possible about the trial and feel comfortable asking the research team any questions about the trial.
Risks associated with the clinical trial drugs
Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe and even life-threatening, and can vary from person to person.
Pola-R-GemOx or R-GemOx
Potential participants will be told about the known side effects of polatuzumab vedotin, rituximab, gemcitabine, and oxaliplatin, and where relevant, also potential side effects, based on human and laboratory studies or knowledge of similar drugs.
Pola-R-GemOx and R-GemOx will be given as an infusion into the vein. Participants will be told about any known side effects of intravenous infusions.
Potential benefits associated with the clinical trial
Participants’ health may or may not improve from participation in the clinical trial, but the information that is collected may help other people who have a similar medical condition in the future.
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For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04182204
Trial Summary
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).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04182204,MO40598,2018-003727-10
Trial Identifier
Polatuzumab Vedotin, Rituximab, Gemcitabine, Oxaliplatin
Treatments
Diffuse Large B-Cell Lymphoma
Condition
Official Title
A Phase III, Open-Label, Multicenter, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX Alone in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL
- Relapsed disease (disease that has recurred following a response that lasted ≥ 6 months from completion of the last line of therapy) or refractory disease (disease that did not respond to or that progressed during therapy or progressed within 6 months (< 6 months) of prior therapy)
- At least one (≥ 1) line of prior systemic therapy:
- Patients may have undergone autologous hematopoietic stem cell transplantation (HSCT) prior to recruitment; In such cases, salvage chemotherapy (e.g., rituximab, dexamethasone, cytarabine, and cisplatin [R-DHAP] and rituximab, ifosfamide, carboplatin, and etoposide phosphate [R-ICE]) will be counted as one line of therapy and conditioning chemotherapy (e.g., BEAM) followed by consolidative autologous HSCT will be counted as one line of therapy
- Patients may have undergone allogeneic HSCT prior to recruitment, so long as they are off all immunosuppressive therapy and have no active GVHD; In such cases, salvage chemotherapy (e.g., R-DHAP and R-ICE) will be counted as one line of therapy and conditioning chemotherapy (e.g., carmustine, etoposide, cytarabine, and melphalan [BEAM]) followed by allogeneic HSCT will be counted as a separate line of therapy
- Participants may have undergone CAR T-cell therapy prior to recruitment. In such cases, cell collection, conditioning chemotherapy, and infusion will be counted as one line of therapy.
- Local therapies (e.g., radiotherapy) will not be considered as lines of treatment
- For participants with a history of the transformation of indolent disease to DLBCL, it is preferred that participants have received at least one treatment for the transformed lymphoma. However, if there are cases where the participants have received an anthracycline-containing chemotherapy regimen (such as R-CHOP) for the indolent lymphoma only, then these participants can be considered as eligible.
- At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- Adequate hematological function
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm,
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
- Contraindication to rituximab, gemcitabine or oxaliplatin
- Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0
- Prior use of polatuzumab vedotin or a gemcitabine plus platinum-based agent combination, recent participation in a clinical trial, and/or treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy within 2 weeks
- Planned autologous or allogenic stem cell transplantation or CAR T-cell therapy at time of recruitment
- Primary or secondary central nervous system (CNS) lymphoma
- Richter's transformation or prior CLL
- Abnormal laboratory values or health conditions, as assessed by the investigator, any known conditions preventing adherence to protocol or active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
- Vaccination with a live vaccine within 4 weeks prior to treatment
- Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug
- Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
For the latest version of this information please go to www.forpatients.roche.com