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Maintenance Obinutuzumab for Central Nervous System Lymphoma

Phase 2
Recruiting
Led By Prakash Ambady
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be within 75 days of completion of first-line treatment regimen; must have achieved objective response (PR or CR/unconfirmed complete response [CRu]) to first-line treatment
CD20+ B-cell primary central nervous system lymphoma (PCNSL) confirmed at the time of diagnosis by histology, cytology, or immunocytochemistry from cerebrospinal fluid (CSF); diagnosis must be documented by pathology report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial looks at whether obinutuzumab can help keep central nervous system lymphoma from coming back after initial treatment.

Who is the study for?
This trial is for patients with B-cell primary central nervous system lymphoma who've responded to initial treatment. They must have good organ function, no history of other cancers or severe infections recently, not be pregnant or breastfeeding, and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests maintenance therapy with Obinutuzumab in patients who've had a complete or partial response after first-line treatment for CNS lymphoma. It's a phase II trial assessing if this immunotherapy can prevent cancer growth and spread.See study design
What are the potential side effects?
Obinutuzumab may cause immune-related reactions, infusion reactions (like fever, chills), low blood cell counts increasing infection risk, tiredness, and potential liver issues. Each patient's side effects could vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I finished my first cancer treatment less than 75 days ago and it worked.
Select...
My lymphoma in the brain was confirmed by tests on my spinal fluid or a biopsy.
Select...
I've had initial treatment with high-dose methotrexate for my cancer.
Select...
I have had a brain MRI showing treatment response within the last 30 days.
Select...
My lymphoma in the CSF or eye is in complete remission without steroids for 2 weeks.
Select...
My kidneys work well enough to clear creatinine over 30 mL/min.
Select...
I can care for myself and perform daily activities.
Select...
I am using or agree to use birth control during and after my treatment with obinutuzumab.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Partial response (PR) or complete response (CR) duration
Secondary outcome measures
Neurocognitive function
Overall survival
Overall survival (OS) after CR
+2 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%
Malignant melanoma
1%
Haemoptysis
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

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (obinutuzumab)Experimental Treatment3 Interventions
Patients receive obinutuzumab IV on days 1 and 2 for the first cycle, and on day 1 for the subsequent cycles, and on day 1 for the subsequent cycles. Cycles repeat every 60 days for 2 years in the absence of disease progression or unacceptable toxicity
Group II: Arm II (observation)Active Control2 Interventions
Patients undergo observation for a total of 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Assessment
2011
Completed Phase 2
~1320
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,287 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
968 Previous Clinical Trials
6,845,726 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
227 Previous Clinical Trials
2,090,543 Total Patients Enrolled

Media Library

Obinutuzumab Clinical Trial Eligibility Overview. Trial Name: NCT02498951 — Phase 2
Central Nervous System B-Cell Lymphoma Research Study Groups: Arm I (obinutuzumab), Arm II (observation)
Central Nervous System B-Cell Lymphoma Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT02498951 — Phase 2
Obinutuzumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT02498951 — Phase 2

Frequently Asked Questions

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

Has the FDA green-lighted Obinutuzumab for usage?

"Our research team has determined that obinutuzumab is likely safe, granting it a score of 2 as there have only been preliminary trials suggesting its safety rather than efficacy."

Answered by AI

How many individuals have been chosen to participate in this clinical investigation?

"The sponsor, Genentech Inc., requires 60 participants that meet the study's eligibility criteria to execute it. Consequently, they are running this trial from two different locations: Providence Portland Medical Center in Cleveland, Ohio and Cleveland Clinic Cancer Center/Fairview Hospital in Hershey, Pennsylvania."

Answered by AI

Is this experiment the inaugural of its kind?

"At the present moment, 100 live clinical trials for Obinutuzumab are underway in 46 countries and 948 cities. The first test was conducted by Genentech Inc. in 2014 with 40 participants across two phases of drug approval; since then, 181 additional tests have been completed."

Answered by AI

Are there any prior trials that have been conducted pertaining to Obinutuzumab?

"Currently, there are 100 trials studying Obinutuzumab and 18 of those studies have advanced to Phase 3. La Jolla is the epicentre for these investigations but in total, 4852 research sites around the world are running experiments with this drug."

Answered by AI

In what geographical areas is this research currently taking place?

"At this moment in time, 11 medical centres are recruiting patients for the trial. These sites include Cleveland, Hershey and Winston-Salem along with 8 other places. To reduce travel expenses associated with being a part of the study, it is advised to pick the clinic closest to your residence."

Answered by AI

Are there vacancies for participants in this research endeavor?

"Affirmative. Clinicaltrials.gov documents indicate that this clinical research is presently enrolling patients, as it first appeared on July 12th 2016 and was recently updated on June 9th 2022. There are 11 sites recruiting 60 participants in total for the trial."

Answered by AI
~7 spots leftby Mar 2025