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Arm I (obinutuzumab for Central Nervous System Lymphoma

Phase 2

Recruiting

Led By Prakash Ambady, MD

Research Sponsored by Providence Health & Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial studies a drug to see if it can keep cancer away in patients who responded to treatment. It uses immunotherapy to stop cancer cells from growing.

Who is the study for?

This trial is for patients with a type of brain lymphoma who've responded to initial treatment. They must have had high-dose methotrexate-based chemo, be within 75 days post-treatment, and show partial or complete cancer response on an MRI. Participants need decent physical function (KPS >=60), acceptable organ function tests, and agree to use effective contraception.Check my eligibility

What is being tested?

The study is testing if the immunotherapy drug Obinutuzumab helps maintain remission in central nervous system lymphoma after initial success from first-line treatments. It's a phase II trial where some patients will receive this maintenance therapy while others may not.See study design

What are the potential side effects?

Obinutuzumab can cause immune-related reactions, which might affect organ functions leading to symptoms like fever or weakness. There could also be infusion-related reactions such as rash or difficulty breathing during administration of the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma in the brain was confirmed by tests on my spinal fluid or a biopsy.

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I finished my first cancer treatment less than 75 days ago and it worked.

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I've had initial treatment with high-dose methotrexate for my cancer.

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I can care for myself and am up more than 50% of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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 - Brief Test of Attention

Neurocognitive function - Grooved Pegboard Test

Neurocognitive function - Hopkins Verbal Learning Test-Revised

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (obinutuzumabExperimental 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

Obinutuzumab

2015

Completed Phase 3

~3250

Cognitive Assessment

2011

Completed Phase 2

~1320

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor

117 Previous Clinical Trials

822,505 Total Patients Enrolled

Prakash Ambady, MDPrincipal InvestigatorProvidence Health & Services

1 Previous Clinical Trials

56 Total Patients Enrolled

Frequently Asked Questions

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

Is obinutuzumab a safe option for patients with regards to adverse effects?

"There is limited data available that suggest obinutuzumab's safety, resulting in it being given a score of 2. Unfortunately, there exists no evidence supporting its efficacy as of yet."

Answered by AI

Are there any opportunities to sign up for this clinical trial currently?

"According to the clinicaltrials.gov website, enrollment for this experiment has already finished as of December 8th 2023. Despite this, there are still 1705 other medical studies that are seeking participants at the present moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response

2024. "Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06175000.

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