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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)
Must not have
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Prior allogenic stem cell transplant (SCT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had lung conditions like pulmonary fibrosis or pneumonia, or my CT scan shows active lung inflammation.
Select...
I have had a stem cell transplant from a donor.
Select...
I had a stem cell transplant using my own cells less than 100 days ago.
Select...
I have or had a brain or spinal cord disease.
Select...
My condition did not improve after treatment with obinutuzumab alone.
Select...
I am currently taking medication that weakens my immune system.
Select...
I have been diagnosed with progressive multifocal leukoencephalopathy.
Select...
I have or had brain lymphoma.
Select...
I have had cancer spread to the lining of my brain and spinal cord.
Select...
I haven't had a live vaccine in the last 4 weeks and won't need one during the study.
Select...
I have had a solid organ transplant.
Select...
I have a specific type of leukemia or lymphoma.
Select...
I have serious heart or lung disease.
Select...
I have not had an active infection or a flare-up of a hidden infection in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2019 Phase 3 trial • 229 Patients • NCT0226457444%
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%
Muscle spasms
14%
Atrial fibrillation
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%
Headache
8%
Iron deficiency
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%
Adenocarcinoma of colon
3%
Acute coronary syndrome
3%
Gastroenteritis
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%
Oesophageal rupture
1%
Respiratory failure
1%
Compartment syndrome
1%
Invasive ductal breast carcinoma
1%
Colorectal cancer
1%
Malignant melanoma
1%
Non-small cell lung cancer
1%
Uterine prolapse
1%
Bronchitis chronic
1%
Peripheral ischaemia
1%
Myelodysplastic syndrome
1%
Haemoptysis
1%
Pleural effusion
1%
Bronchopulmonary aspergillosis
1%
Cardiac failure congestive
1%
Gastritis
1%
Concussion
1%
Arthritis
1%
Inclusion body myositis
1%
Colorectal cancer metastatic
1%
Ischaemic stroke
1%
Bacterial sepsis
1%
Leukopenia
1%
Acute myocardial infarction
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%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~5860
Obinutuzumab
2014
Completed Phase 3
~3470
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,456 Previous Clinical Trials
1,097,401 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,225 Previous Clinical Trials
896,149 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe nerve damage in my hands or feet.I have had lung conditions like pulmonary fibrosis or pneumonia, or my CT scan shows active lung inflammation.I have had a stem cell transplant from a donor.I had a stem cell transplant using my own cells less than 100 days ago.I can take care of myself and am up and about more than half of the day.My liver, blood, and kidney functions are all within normal ranges.I have or had a brain or spinal cord disease.My condition did not improve after treatment with obinutuzumab alone.I haven't had cancer or lymphoma treatment or immune therapy in the last 4 weeks or 5 half-lives of the drug.I am currently taking medication that weakens my immune system.I have a recent biopsy or an older one not affected by major changes.My blood cancer is expected to have CD20 and has not improved after treatment.I have been diagnosed with progressive multifocal leukoencephalopathy.I have had severe immune-related side effects from treatment, except for hormone issues managed with medication.I haven't had cancer treatment or experimental therapy in the last 4 weeks.I have or had brain lymphoma.I haven't taken more than 25mg/day of steroids like prednisone in the last 4 weeks.I have an autoimmune condition, but it's not hypothyroidism or Type 1 diabetes.I have had cancer spread to the lining of my brain and spinal cord.I haven't had a live vaccine in the last 4 weeks and won't need one during the study.I have not had major surgery or a serious injury in the last 28 days.I have had a solid organ transplant.I have a specific type of leukemia or lymphoma.I have serious heart or lung disease.I have not had an active infection or a flare-up of a hidden infection in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab
- Group 2: Polatuzumab Vedotin
- Group 3: Imaging Sub-study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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