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Monoclonal Antibodies

Polatuzumab Vedotin + R-CHP vs R-CHOP for Diffuse Large B-Cell Lymphoma (POLARIX Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Left ventricular ejection fraction (LVEF) greater than or equal to 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months after enrollment (up to approximately 65 months)
Awards & highlights

POLARIX Trial Summary

This trial will compare the effects of two different treatments for people with a type of blood cancer called diffuse large B-cell lymphoma.

Who is the study for?
This trial is for adults with previously untreated CD20-positive diffuse large B-cell lymphoma. Participants must have a life expectancy of at least 12 months, good heart function (LVEF ≥50%), and an ECOG Performance Status of 0-2. They should agree to use contraception and not donate sperm or eggs. Exclusions include prior organ transplants, certain other lymphomas, CNS involvement, recent live vaccines, significant ECG abnormalities, major surgery within the last month, HIV or hepatitis infection among others.Check my eligibility
What is being tested?
The study compares Polatuzumab Vedotin combined with R-CHP versus the standard R-CHOP therapy in treating diffuse large B-cell lymphoma. It's a Phase III trial where participants are randomly assigned to either treatment group in a double-blind manner; neither they nor the researchers know who receives which treatment until after the results are collected.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to monoclonal antibodies like Polatuzumab Vedotin or Rituximab; blood disorders from Cyclophosphamide; heart problems from Doxorubicin; nerve damage from Vincristine; immune system suppression leading to infections and various infusion-related reactions.

POLARIX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able to care for myself and perform daily activities.
Select...
My heart pumps well, with an ejection fraction of 50% or more.
Select...
I have CD20-positive DLBCL and have not been treated for it.
Select...
I agree to use birth control or remain abstinent and not donate eggs.
Select...
I agree to not have unprotected sex or donate sperm.

POLARIX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months after enrollment (up to approximately 65 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after enrollment (up to approximately 65 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Secondary outcome measures
Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
EORTC QLQ-C30 Treatment-Related Symptoms Score
+16 more

Side effects data

From 2019 Phase 1 & 2 trial • 231 Patients • NCT01691898
51%
Fatigue
44%
Diarrhoea
37%
Neuropathy peripheral
32%
Nausea
30%
Neutropenia
29%
Constipation
25%
Peripheral sensory neuropathy
24%
Insomnia
24%
Pyrexia
21%
Decreased appetite
17%
Abdominal pain
17%
Vomiting
17%
Asthenia
17%
Dyspnoea
16%
Headache
16%
Alopecia
14%
Anaemia
14%
Arthralgia
14%
Cough
13%
Hyperglycaemia
11%
Hypokalaemia
11%
Dizziness
11%
Back pain
11%
Pain in extremity
11%
Myalgia
10%
Urinary tract infection
10%
Oropharyngeal pain
10%
Vision blurred
10%
Weight decreased
10%
Dehydration
10%
Night sweats
10%
Oedema peripheral
8%
Hypomagnesaemia
8%
Paraesthesia
8%
Muscle spasms
8%
Upper respiratory tract infection
8%
Dry mouth
8%
Chills
8%
Pain
6%
Dyspepsia
6%
Musculoskeletal pain
6%
Gastrooesophageal reflux disease
6%
Chest pain
6%
Erythema
6%
Hypotension
6%
Nasal congestion
5%
Sepsis
5%
Pruritus
5%
Hypoaesthesia
5%
Dry skin
5%
Thrombocytopenia
5%
Infusion related reaction
5%
Restless legs syndrome
5%
Tachycardia
5%
Rash
5%
Epistaxis
5%
Rhinorrhoea
5%
Depression
3%
Alanine aminotransferase increased
3%
Rash pruritic
3%
General physical health deterioration
3%
Abdominal pain lower
3%
Vertigo
3%
Hyperhidrosis
3%
Peripheral motor neuropathy
3%
Acute kidney injury
3%
Dry eye
3%
Abdominal discomfort
3%
Haemorrhoids
3%
Candida infection
3%
Oral candidiasis
3%
Aspartate aminotransferase increased
3%
Blood creatinine increased
3%
Hyperuricaemia
3%
Hypophosphataemia
3%
Muscular weakness
3%
Dysgeusia
3%
Anxiety
3%
Pleural effusion
3%
Nasopharyngitis
3%
Febrile neutropenia
2%
Non-cardiac chest pain
2%
Clostridial sepsis
2%
Sinus congestion
2%
Ear pain
2%
Herpes zoster
2%
Memory impairment
2%
Joint stiffness
2%
Rhinitis
2%
Dysuria
2%
Gastroenteritis
2%
Peripheral swelling
2%
Pneumonia
2%
Bone pain
2%
Productive cough
2%
Contusion
2%
Atrial fibrillation
2%
Colonic fistula
2%
Atrial flutter
2%
Chronic kidney disease
2%
Urinary retention
2%
Cardiac failure congestive
2%
Duodenal perforation
2%
Device related infection
2%
Influenza
2%
Lung infection
2%
Septic shock
2%
Viral diarrhoea
2%
Wound secretion
2%
Ganglioneuroma
2%
Cerebrovascular accident
2%
Respiratory failure
2%
Eye pain
2%
Visual impairment
2%
Abdominal distension
2%
Abdominal pain upper
2%
Dysphagia
2%
Gastrointestinal pain
2%
Gait disturbance
2%
Procedural pain
2%
Blood potassium decreased
2%
Weight increased
2%
White blood cell count decreased
2%
Hypercalcaemia
2%
Hyponatraemia
2%
Muscle tightness
2%
Flushing
2%
Coagulopathy
2%
Cardiac failure
2%
Dysphonia
2%
Dyspnoea exertional
2%
Squamous cell carcinoma
2%
Gastrointestinal haemorrhage
2%
Upper gastrointestinal haemorrhage
2%
Sudden death
2%
Urosepsis
2%
Malaise
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Cohort C (FL): RTX + Polatuzumab

POLARIX Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: R-CHP plus Vincristine Placebo plus Polatuzumab VedotinExperimental Treatment6 Interventions
Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m^2) IV, cyclophosphamide 750 mg/m^2 IV, and doxorubicin 50 mg/m^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m^2 IV will be administered as monotherapy in Cycles 7 and 8.
Group II: R-CHOP plus Polatuzumab Vedotin PlaceboPlacebo Group6 Interventions
Participants will receive placebo for polatuzumab vedotin, rituximab 375 mg/m^2 IV, cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV (maximum 2 milligrams per dose [mg/dose]) on Day 1 and prednisone 100 mg/day PO on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m^2 IV will be administered as monotherapy in Cycles 7 and 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3780
Doxorubicin
2012
Completed Phase 3
~7940
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,088,169 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
887,597 Total Patients Enrolled

Media Library

Polatuzumab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03274492 — Phase 3
Non-Hodgkin's Lymphoma Research Study Groups: R-CHOP plus Polatuzumab Vedotin Placebo, R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
Non-Hodgkin's Lymphoma Clinical Trial 2023: Polatuzumab Vedotin Highlights & Side Effects. Trial Name: NCT03274492 — Phase 3
Polatuzumab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03274492 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total subject pool for this clinical research?

"Unfortunately, this study is no longer admitting patients. The trial was originally posted on November 16th, 2017 and the last update was on August 29th, 2022. There are presently 1816 other clinical trials for diffuse large b-cell lymphoma (dlbcl) and 1489 trials for Polatuzumab Vedotin that are actively recruiting participants."

Answered by AI

In how many different medical facilities is this research being conducted today?

"64 patients are currently enrolled, with CancerCare Manitoba (CCMB) in Winnipeg, Texas Oncology San Antonio Medical Center in San Antonio, and Oncology Associates of Southwest Virginia, Inc. in Blacksburg being some of the notable enrolment sites. There are also 64 other locations where patients have joined this trial."

Answered by AI

What are the most similar trials to Polatuzumab Vedotin in terms of purpose and design?

"Polatuzumab Vedotin was first researched in 1993 at the National Institutes of Health Clinical Center. As of now, there have been 2421 completed clinical trials and 1489 ongoing studies. A large portion of these live trials are being conducted out of Winnipeg, Manitoba."

Answered by AI

Has Polatuzumab Vedotin completed the necessary steps for FDA approval?

"Polatuzumab Vedotin has received a 3 for safety from our team at Power. This is because Polatuzumab Vedotin is in Phase 3 trials, which means that though there is data supporting efficacy, multiple rounds of tests have been conducted to support safety."

Answered by AI

What are the conditions that Polatuzumab Vedotin is approved to treat?

"Polatuzumab Vedotin can be used to attack and eliminate lung cancers, small cell lung cancer (sclc), as well as thyroiditis."

Answered by AI

Are we looking for more people to participate in this experiment?

"This trial is no longer recruiting patients. The last update to the posting was on 8/29/2022 and it was first posted on 11/16/2017. There are 1816 other trials currently enrolling patients with diffuse large b-cell lymphoma (dlbcl) and 1489 trials for Polatuzumab Vedotin that are actively seeking patients."

Answered by AI

Can adults of any age participate in this research project?

"In order to take part in this clinical trial, patients must be aged between 18-80. There are 697 other studies for those under 18 and 2861 for seniors."

Answered by AI

How can I sign up to help test this new medication?

"This study is looking for 1000 participants that have diffuse large b-cell lymphoma (dlbcl) and are between 18-80 years old. The most important requirements for applicants are as follows: Must be able to provide either archival or freshly collected tumor tissue, Male participants must agree to use a condom during intercourse and not donate sperm, Participants must be previously untreated with CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B"

Answered by AI
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~38 spots leftby Jun 2024