← Back to Search

Monoclonal Antibodies

Combination Therapy for Non-Hodgkin's Lymphoma

Phase 1 & 2
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 0-2
Histologically-confirmed hematologic malignancy that is expected to express CD20 (Relapsed after or refractory to respond to at least one prior treatment regimen; no available treatment options that are expected to prolong survival or patients refusing chemotherapy or autologous stem cell transplant (SCT). Note: The expansion part is restricted to relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Awards & highlights

Study Summary

This trial is looking at the safety and effectiveness of a new combination treatment for relapsed or refractory B-cell non-Hodgkin's lymphoma. This combination includes the drugs glofitamab and obinutuzumab.

Who is the study for?
Adults with B-cell Non-Hodgkin's Lymphoma that has come back or didn't respond to treatment, and who have no other life-prolonging therapy options. Participants must have at least one measurable lesion, be in relatively good health (ECOG 0-2), and have proper organ function. They can't join if they've had certain autoimmune diseases, lung conditions, recent cancer treatments, transplants, infections or vaccinations.Check my eligibility
What is being tested?
The trial is testing a combination of drugs including Glofitamab and Atezolizumab or Polatuzumab Vedotin for safety and effectiveness in treating lymphoma. It aims to find the highest dose patients can take without serious side effects (MTD) and suggests a Phase II dose (RP2D). There's also a sub-study using an imaging tracer to see how T-cells are affected by the treatment.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system affecting different organs, infusion-related reactions from the drug entering the body, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects will depend on which drug combination is used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of the day.
Select...
My blood cancer is expected to have CD20 and has not improved after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in CD8 Tumor Volume Based on 89Zr-PET/CT
Change in Maximum Standardized Update Value (SUVmax) Based on 89Zr-PET/CT Scans
Change in Mean SUV (SUVmean) Based on 89Zr-PET/CT Scans
+2 more
Secondary outcome measures
Anti-Drug Antibody (ADA) Formation
Area Under the Concentration-Time Curve (AUC) for Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
CD20-Positive B-Cell Reduction
+22 more

Side effects data

From 2019 Phase 3 trial • 229 Patients • NCT02264574
44%
Neutropenia
35%
Thrombocytopenia
35%
Diarrhea
29%
Cough
24%
Arthralgia
23%
Infusion related reaction
19%
Fatigue
19%
Back pain
19%
Hypertension
17%
Anaemia
17%
Constipation
17%
Pyrexia
16%
Upper respiratory tract infection
15%
Rash maculo-papular
14%
Atrial fibrillation
14%
Muscle spasms
13%
Hyperuricaemia
13%
Nausea
13%
Nasopharyngitis
12%
Insomnia
12%
Urinary tract infection
12%
Oedema peripheral
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Dyspnoea
11%
Vomiting
11%
Pain in extremity
11%
Dizziness
10%
Cataract
10%
Decreased appetite
9%
Spontaneous haematoma
9%
Anxiety
9%
Fall
9%
Rash
8%
Iron deficiency
8%
Headache
8%
Abdominal pain
8%
Dyspepsia
8%
Vision blurred
8%
Pruritus
7%
Bronchitis
7%
Lacrimation increased
7%
Respiratory tract infection
7%
Blood creatine increased
7%
Productive cough
7%
Oropharyngeal pain
7%
Gastrooesophageal reflux disease
6%
Hypokalaemia
6%
Dry eye
6%
Chills
6%
Myalgia
6%
Depression
6%
Dry Skin
6%
Ecchymosis
6%
Onychoclasis
6%
Palpitations
6%
Stomatitis
6%
Peripheral swelling
6%
Epistaxis
5%
Herpes zoster
5%
Increased tendency to bruise
5%
Hyperglycaemia
5%
Musculoskeletal pain
5%
Haematuria
5%
Petechiae
5%
Cellulitis
5%
Contusion
4%
Tremor
4%
Febrile neutropenia
3%
Acute coronary syndrome
3%
Gastroenteritis
3%
Adenocarcinoma of colon
3%
Weight decreased
2%
Septic shock
2%
Femur fracture
2%
Osteoarthritis
2%
Transient ischaemic attack
2%
Cardiac arrest
2%
Angina pectoris
2%
Death
2%
Cerebrovascular accident
2%
Acute kidney injury
2%
Renal failure
1%
Non-small cell lung cancer
1%
Pleural effusion
1%
Haemoptysis
1%
Malignant melanoma
1%
Uterine prolapse
1%
Bronchitis chronic
1%
Ischaemic stroke
1%
Peripheral ischaemia
1%
Bronchopulmonary aspergillosis
1%
Leukopenia
1%
Oesophageal rupture
1%
Concussion
1%
Arthritis
1%
Inclusion body myositis
1%
Colorectal cancer
1%
Cardiac failure congestive
1%
Bacterial sepsis
1%
Invasive ductal breast carcinoma
1%
Compartment syndrome
1%
Respiratory failure
1%
Gastritis
1%
Colorectal cancer metastatic
1%
Myelodysplastic syndrome
1%
Pericarditis
1%
Stress cardiomyopathy
1%
Goitre
1%
Haemorrhoids
1%
Impaired gastric emptying
1%
Proctitis
1%
Small intestinal obstruction
1%
Catheter site haematoma
1%
Multi-organ disorder
1%
Cholelithiasis
1%
Abscess
1%
Bursitis infective staphylococcal
1%
Erysipelas
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Infective aneurysm
1%
Listeria sepsis
1%
Lower respiratory tract infection
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia klebsiella
1%
Prostate infection
1%
Sinusitis fungal
1%
Urosepsis
1%
Jaw fracture
1%
Pubis fracture
1%
Rib fracture
1%
Spinal compression fracture
1%
Thoracic vertebral fracture
1%
Traumatic haematoma
1%
Upper limb fracture
1%
Diabetes mellitus inadequate control
1%
Adenocarcinoma gastric
1%
Basal cell carcinoma
1%
Benign renal neoplasm
1%
Squamous cell carcinoma
1%
Syncope
1%
Acute psychosis
1%
Complete Suicide
1%
Soft tissue infection
1%
Osteoma
1%
Atrial tachycardia
1%
Retinal detachment
1%
Herpes Zoster
1%
Oral herpes
1%
Pharyngitis
1%
Streptococcal bacteraemia
1%
Cardiac failure
1%
Myocardial infarction
1%
Sudden Death
1%
Incisional hernia
1%
Hypercalcaemia
1%
Hypomagnesaemia
1%
Aplastic anaemia
1%
Acute myocardial infarction
1%
Inguinal hernia
1%
Large intestine polyp
1%
Cerebral ischaemia
1%
Depressed level of consciousness
1%
Confusional state
1%
Nephrolithiasis
1%
Urinary retention
1%
Benign prostatic hyperplasia
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
IBR+OB
CLB+OB

Trial Design

3Treatment groups
Experimental Treatment
Group I: Polatuzumab VedotinExperimental Treatment4 Interventions
Participants will receive Glofitamab in combination with polatuzumab vedotin up to the MTD.
Group II: Imaging Sub-studyExperimental Treatment3 Interventions
Participants will undergo positive-emission tomography/computed tomography (PET/CT) at screening, followed by an "Imaging Cycle," to replace Cycle 1 of the main study. Eligible participants will have the option roll-over to the atezolizumab arm of the main study from Cycle 2 onwards.
Group III: AtezolizumabExperimental Treatment4 Interventions
Participants will receive Glofitamab in combination with Atezolizumab up to the maximum tolerated dose (MTD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Tocilizumab
2012
Completed Phase 4
~1840
Atezolizumab
2016
Completed Phase 3
~6040
Obinutuzumab
2015
Completed Phase 3
~3250
Polatuzumab Vedotin
2019
Completed Phase 2
~820

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,088,889 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,317 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03533283 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Atezolizumab, Polatuzumab Vedotin, Imaging Sub-study
Non-Hodgkin's Lymphoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03533283 — Phase 1 & 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03533283 — Phase 1 & 2

Frequently Asked Questions

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

How many participants is the maximum capacity for this research endeavor?

"Confirmed. Per the information published on clinicaltrials.gov, this investigation is presently recruiting participants and was first posted on May 8th 2018. For a successful trial completion, 280 individuals need to be recruited from 1 medical centre."

Answered by AI

To what end is Obinutuzumab usually administered?

"Obinutuzumab is commonly employed to treat dlbcl, but can also be utilized in the care of sjia and certain malignant neoplasms such as small cell lung cancer."

Answered by AI

Could you provide information about preceding research on Obinutuzumab?

"At this time, 513 Obinutuzumab experiments are in progress. Of these trials, 98 have reached phase 3 and 24630 different sites across the world are conducting them. The majority of locations for these tests are located in Harvey, Illinois."

Answered by AI

Is there availability for participants in this examination?

"According to clinicaltrials.gov, this research is currently accepting participants. The original posting date was 8th of May 2018 and the latest update occurred on November 1st 2022."

Answered by AI

Has this form of experimentation been done before?

"Currently, 513 active studies utilizing Obinutuzumab are running across 82 nations and 1947 cities. This medication was initially trialled in 2008 by Hoffmann-La Roche with 720 test subjects over the course of two stages - Phase 2 drug approval being one of them. Since then, 349 trials have concluded."

Answered by AI
~84 spots leftby Sep 2026