← Back to Search

Monoclonal Antibodies

Polatuzumab Vedotin for Non-Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Brad Haverkos
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years of follow up
Awards & highlights
No Placebo-Only Group

Summary

This is a phase II multicenter, open-label study of polatuzumab vedotin administered by IV infusion in combination with standard doses of bendamustine (B) and rituximab (R) in transplant-eligible patients with relapsed or refractory DLBCL. A total of 22 patients will be enrolled over a period of 2 years through the University of Colorado and additional study sites if applicable. Study treatment will be given in 21-day cycles for patients with DLBCL.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years of follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years of follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
2-yr progression free survival (PFS)
Cell of Origin analysis
Complete response at primary response
+7 more

Side effects data

From 2019 Phase 1 & 2 trial • 231 Patients • NCT01691898
58%
Fatigue
46%
Neuropathy peripheral
42%
Diarrhoea
42%
Nausea
29%
Peripheral sensory neuropathy
29%
Decreased appetite
27%
Asthenia
25%
Neutropenia
25%
Cough
24%
Constipation
22%
Vomiting
20%
Pain in extremity
19%
Abdominal pain
19%
Arthralgia
19%
Dyspnoea
17%
Dizziness
17%
Anaemia
15%
Pyrexia
14%
Hypokalaemia
14%
Insomnia
14%
Dyspepsia
14%
Back pain
14%
Influenza like illness
14%
Oedema peripheral
14%
Headache
12%
Weight decreased
12%
Alopecia
10%
Chest pain
10%
Muscular weakness
10%
Pruritus
10%
Muscle spasms
10%
Hypomagnesaemia
10%
Bone pain
10%
Myalgia
8%
Peripheral motor neuropathy
8%
Dry mouth
8%
Musculoskeletal pain
8%
Anxiety
7%
Neutrophil count decreased
7%
Abdominal pain upper
7%
Chills
7%
White blood cell count decreased
7%
Hyperglycaemia
7%
Hyperhidrosis
7%
Night sweats
7%
Depression
5%
Memory impairment
5%
Dehydration
5%
Hypophosphataemia
5%
Dysuria
5%
Productive cough
5%
Taste Disorder
5%
Tachycardia
5%
Abdominal discomfort
5%
Gait disturbance
5%
Dysgeusia
5%
Hypertension
5%
Rash
3%
Thrombocytopenia
3%
Peripheral swelling
3%
Urinary tract infection
3%
Alanine aminotransferase increased
3%
Hypoaesthesia
3%
Febrile neutropenia
3%
Upper respiratory tract infection
3%
Vision blurred
3%
Abdominal distension
3%
Toothache
3%
Oral candidiasis
3%
Hyponatraemia
3%
Nasal congestion
3%
Dysphonia
3%
Acute kidney injury
3%
Malaise
3%
Fall
2%
Sinusitis
2%
Skin Abrasion
2%
Benign neoplasm of skin
2%
Rash pruritic
2%
Gout
2%
Orthostatic hypotension
2%
Erythema
2%
Vertigo
2%
Abdominal pain lower
2%
Contusion
2%
Paraesthesia
2%
Haematoma
2%
Hernial eventration
2%
General physical health deterioration
2%
Cholecystitis acute
2%
Pulmonary congestion
2%
Influenza
2%
Pharyngitis
2%
Groin pain
2%
Restless legs syndrome
2%
Syncope
2%
Tremor
2%
Rash erythematous
2%
Gastroenteritis viral
2%
Pancreatitis
2%
Rectal haemorrhage
2%
Subileus
2%
Axillary pain
2%
Hepatic steatosis
2%
Hepatocellular injury
2%
Hepatomegaly
2%
Bronchitis
2%
Clostridium difficile infection
2%
Febrile infection
2%
Lung disorder
2%
Hypotension
2%
Lymphadenopathy
2%
Ear discomfort
2%
Visual impairment
2%
Pain
2%
Oesophageal candidiasis
2%
Aspartate aminotransferase increased
2%
Blood creatinine increased
2%
Platelet count decreased
2%
Hypercalcaemia
2%
Hyperuricaemia
2%
Hypoxia
2%
Dermatitis acneiform
2%
Nasopharyngitis
2%
Infusion related reaction
2%
Epistaxis
2%
Chest discomfort
2%
Fistula of small intestine
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (FL+DLBCL): RTX+Polatuzumab,Then RTX+Pinatuzumab
Cohort H (Expansion, DLBCL): Obinutuzumab + Polatuzumab
Cohort E (FL+DLBCL): Obinutuzumab + Polatuzumab
Cohort G (Expansion, FL): Obinutuzumab + Polatuzumab
Arm A (FL+DLBCL): RTX+Pinatuzumab,Then RTX+Polatuzumab
Cohort C (FL): RTX + Polatuzumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Polatuzumab + BR (minimum 3 cycles)Experimental Treatment1 Intervention
Patients will be treated with a minimum of 3 cycles up to a maximum six cycles to optimize response prior to ASCT (stem cell transplant) per investigator discretion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polatuzumab Vedotin
2019
Completed Phase 2
~820

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,803 Previous Clinical Trials
2,822,147 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,465 Total Patients Enrolled
Brad HaverkosPrincipal InvestigatorUniversity of Colorado, Denver
~0 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top