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Obinutuzumab for CNS 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

Must not have

Clinical evidence of extra-central nervous system (CNS) (systemic) non-Hodgkin lymphoma

Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks prior to study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have non-Hodgkin lymphoma outside of my brain and spinal cord.

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I haven't had a serious infection or needed IV antibiotics in the last 4 weeks.

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I am currently pregnant or breastfeeding.

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I have not had major surgery in the last 4 weeks.

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I am HIV positive.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Partial response (PR) or complete response (CR) duration

Secondary study objectives

Neurocognitive function - Brief Test of Attention

Neurocognitive function - Grooved Pegboard Test

Neurocognitive function - Hopkins Verbal Learning Test-Revised

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2014

Completed Phase 3

~3470

Cognitive Assessment

2011