Primary Central Nervous System LymphomaPhase 2NCT06175000
Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response
A Phase 2 study testing Cognitive Assessment, Obinutuzumab and Quality of Life Assessment in people with Primary Central Nervous System Lymphoma, run by Providence Health & Services at 7 sites in United States.
Trial summary
This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- Cognitive Assessment, Obinutuzumab and Quality of Life Assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Mar 2024to 15 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose methotrexate is defined as >= 3 grams/m^2; methotrexate dose reduction for creatinine clearance < 100 ml/min is permitted
- Must be within 75 days of completion of first-line treatment regimen at the time of randomization; must have achieved objective response (PR or CR/unconfirmed complete response [CRu]) to first-line treatment
- Brain magnetic resonance imaging (MRI) documenting objective response must be obtained within 30 days before randomization
- If CSF was positive for lymphoma cells at diagnosis or during first-line treatment and/or a slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; Note: CR requires complete disappearance of all enhancing abnormalities on gadolinium-enhanced MRI; if CSF was positive for lymphoma cells at diagnosis or during first-line treatment and/or slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; for CRu, some patients will have a small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; it is often difficult to ascertain whether this represents a residual nidus of tumor or scar tissue; if the abnormality does not change or slowly involutes without therapy and corticosteroids, it is reasonable to categorize as a CRu; at the time CR/CRu is determined, the patient should not have used corticosteroids for at least two weeks
- Karnofsky performance status (KPS) >= 60; Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
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- Signed informed consent form (ICF)
- Ability and willingness to comply with the requirements of the study protocol
- Total bilirubin < 3 x the upper limit of normal (ULN), ≤ 7 days before date of randomization
- Creatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft-Gault formula), ≤ 7 days before date of randomization
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 x ULN, ≤7 days before date of randomization
- Platelet ≤ 75,000 cells/mm^3, ≤ 7 days before date of randomization
- Hemoglobin > 9 g/dL, ≤ 7 days before date of randomization
- Absolute neutrophil count > 1.5 x 10^3 cells/mm^3, ≤ 7 days before date of randomization
- Surgically sterile or agree to use effective contraception using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly while receiving obinutuzumab and >= 18 months after the last dose of obinutuzumab for women, and 180 days after the last dose of obinutuzumab for men
Who cannot join
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Clinical evidence of extra-central nervous system (CNS) (systemic) non-Hodgkin lymphoma
- Known hypersensitivity to any of the study drugs
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible; patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for >= 2 years prior to randomization
- 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 randomization
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- Major surgery within 4 weeks prior to study randomization
- Known infection with human immunodeficiency virus (HIV)
- Positive hepatitis serologies:
- Hepatitis B (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management
- Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis
- Women who are pregnant or lactating
- Vaccination with a live vaccine a minimum of 4 weeks prior to study randomization
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 6 recruiting
- Recruiting
University of Vermont
Burlington, Vermont, 05405
Isza Parchini, 802-656-9447, isza.parchini@uvahealth.org
George Davis, george.davis@uvmhealth.org
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Nija Desai, 434-982-6455, NND2A@uvahealth.org
Patrick Heffernan, 434-243-9508, YWW2NJ@uvahealth.org
- Withdrawn
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Pennsylvania State University
Hershey, Pennsylvania, 17033
Micaiah Grien, 717-531-0003 ext. 283063, mgrien@pennstatehealth.psu.edu
Sara Craig, 717-531-0003 ext. 285799, scraig2@pennstatehealth.psu.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Lindey Myers, 917-453-2968, myersl1@mskcc.org
Christian Grommes, MD
- Recruiting
Providence Health & Services; Providence Neurological Specialties
Portland, Oregon, 97225
Kai Darke, 503-216-0627, kai.darke@providence.org
Kimberly Perry, 971-231-8245, kimberly.perry2@providence.org
- Recruiting
Ivy Center for Advanced Brain Tumor Treatment; Swedish Neuroscience Institute
Seattle, Washington, 98122
Gary Brown, 206-320-2608, gary.brown@swedish.org
Nathan Hansen, 206-320-3542, nathan.hansen@swedish.org
About this study
Official title: Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma Complete or Partial Responders
This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the effect of maintenance obinutuzumab on duration of response (partial response [PR] or complete response [CR]) in patients with CD20+ B-cell primary central nervous system lymphoma (PCNSL) who attain PR or CR to first-line treatment with high-dose methotrexate-based chemotherapy.
SECONDARY OBJECTIVES:
- To evaluate overall survival after PR or CR (overall survival [OS]-PRCR). II. To evaluate neurocognitive function, quality of life, and neuroimaging as indicators of neurotoxicity.
III. Progression-free survival (PFS) and overall survival (OS) will be calculated.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (MAINTENANCE THERAPY): Patients receive obinutuzumab intravenously (IV) on days 1 and 2 for the first cycle, 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.
ARM II (OBSERVATION): Patients undergo observation for a total of 2 years.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- Cognitive Assessment, Obinutuzumab, Quality of Life Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive AssessmentProcedure or surgery
Ancillary studies to evaluate neurocognitive function at study entry and at 2 years after study entry.
ObinutuzumabBiological
Also called Anti-CD20 Monoclonal Antibody R7159, GA-101, GA101, Gazyva
Given IV
Quality of Life AssessmentOther
Ancillary studies to evaluate quality of life at study entry and at 2 years after study entry.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (obinutuzumab | Experimental | 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. Receives: Procedure: Cognitive Assessment; Biological: Obinutuzumab; Other: Quality of Life Assessment |
| Arm II (observation) | Active comparator | Patients undergo observation for a total of 2 years. Receives: Procedure: Cognitive Assessment; Other: Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial response (PR) or complete response (CR) duration
PR or CR duration will be assessed using Kaplan-Meier product limit estimates and compared between patients with maintenance versus without obinutuzumab maintenance using the log-rank test. In addition, the Cox proportional hazard model will be used to estimate hazard ratios.
Measured: From the date of brain magnetic resonance imaging (MRI) after completion of first-line treatment which confirms PR or CR, to disease progression or death, assessed up to 2 years
Secondary outcomes (10)
Overall survival (OS) after CR
OS after PR or CR will be assessed using Kaplan-Meier product limit estimates and compared between patients with maintenance versus without obinutuzumab maintenance using the log-rank test. In addition, the Cox proportional hazard model will be used to estimate hazard ratios.
Measured: From the date of brain MRI after completion of first-line treatment which confirms PR or CR, to death, assessed up to 2 years
Neurocognitive function - Wechsler Adult Intelligence Scale
Will be measured by the Wechsler Adult Intelligence Scale. Scale range 0 to 16 Forward; 0 to 14 Backward. Higher the score means better outcome. Longitudinal data of neurocognitive function will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Measured: Up to 2 years
Quality of life (QOL) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain Neoplasm 20-item
Will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Brain Cancer Module-20 (EORTC QLQ-BN20) questionnaire. Scale 20 to 80 points. Higher score means worse outcome. Longitudinal data of QOL will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Measured: Up to 2 years
Progression free survival (PFS)
PFS will be assessed using Kaplan-Meier product limit estimates and compared between patients with obinutuzumab maintenance versus without maintenance using the log-rank test. Longitudinal data of neurocognitive function and QOL will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Measured: From the start date of first-line primary central nervous system lymphoma (PCNSL) treatment to disease progression or death, assessed up to 2 years
Overall survival
OS will be assessed using Kaplan-Meier product limit estimates and compared between patients with obinutuzumab maintenance versus without maintenance using the log-rank test. Longitudinal data of neurocognitive function and QOL will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Measured: From the start date of first-line PCNSL treatment to death, assessed up to 2 years.
Neurocognitive function - Hopkins Verbal Learning Test-Revised
Will be measured by the Hopkins Verbal Learning Test-Revised. Test evaluates total recall, delayed recall, percent of retention, and recognition. Higher score means better outcome. Longitudinal data of neurocognitive function will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Measured: Up to 2 years
Neurocognitive function - Grooved Pegboard Test
Will be measured by the Grooved Pegboard Test. Scale 0 seconds to time of completion in minutes and seconds. Higher time to completion means worse outcome. Longitudinal data of neurocognitive function will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Measured: Up to 2 years
Neurocognitive function - Trail Making Test
Will be measured by the Trail Making Test. Scale Part A: 0 seconds to 100 seconds (time of greater than 100 seconds discontinues the test. Scale Part B: 0 seconds to 300 seconds (time of greater than 300 seconds discontinues the test. Number of errors recorded. Higher time to completion and greater number of errors means worse outcome. Longitudinal data of neurocognitive function will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Measured: Up to 2 years
Neurocognitive function - Brief Test of Attention
Will be measured by the Trail Making Test. Scale 0 to 20 points. Higher score mean better outcome. Longitudinal data of neurocognitive function will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Measured: Up to 2 years
Quality of life (QOL) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item
Will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Core 30-item (EORTC QLQ-C30) questionnaire. Scale 30 to 126 points. Higher score means worse outcome. Longitudinal data of QOL will be analyzed using a linear mixed model and toxicity indicators will be assessed using a chi-square or exact test.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start13 Mar 2024
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prakash Ambady, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175000
- Sponsor's protocol ID
- PHS-OB-PCNSL-01
- Other IDs
- ML29496
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma Complete or Partial Responders
- ClinicalTrials.gov ID
- NCT06175000
- Acronym / sponsor ID
- PHS-OB-PCNSL-01
- Conditions
- Primary Central Nervous System Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.
Detailed description
PRIMARY OBJECTIVE:
- To determine the effect of maintenance obinutuzumab on duration of response (partial response [PR] or complete response [CR]) in patients with CD20+ B-cell primary central nervous system lymphoma (PCNSL) who attain PR or CR to first-line treatment with high-dose methotrexate-based chemotherapy.
SECONDARY OBJECTIVES:
- To evaluate overall survival after PR or CR (overall survival [OS]-PRCR). II. To evaluate neurocognitive function, quality of life, and neuroimaging as indicators of neurotoxicity.
III. Progression-free survival (PFS) and overall survival (OS) will be calculated.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (MAINTENANCE THERAPY): Patients receive obinutuzumab intravenously (IV) on days 1 and 2 for the first cycle, 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.
ARM II (OBSERVATION): Patients undergo observation for a total of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (obinutuzumab | Experimental | Procedure: Cognitive Assessment, Biological: Obinutuzumab, Other: Quality of Life AssessmentPatients 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. |
| Arm II (observation) | Active comparator | Procedure: Cognitive Assessment, Other: Quality of Life AssessmentPatients undergo observation for a total of 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose methotrexate is defined as >= 3 grams/m^2; methotrexate dose reduction for creatinine clearance < 100 ml/min is permitted
- Must be within 75 days of completion of first-line treatment regimen at the time of randomization; must have achieved objective response (PR or CR/unconfirmed complete response [CRu]) to first-line treatment
- Brain magnetic resonance imaging (MRI) documenting objective response must be obtained within 30 days before randomization
- If CSF was positive for lymphoma cells at diagnosis or during first-line treatment and/or a slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; Note: CR requires complete disappearance of all enhancing abnormalities on gadolinium-enhanced MRI; if CSF was positive for lymphoma cells at diagnosis or during first-line treatment and/or slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; for CRu, some patients will have a small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; it is often difficult to ascertain whether this represents a residual nidus of tumor or scar tissue; if the abnormality does not change or slowly involutes without therapy and corticosteroids, it is reasonable to categorize as a CRu; at the time CR/CRu is determined, the patient should not have used corticosteroids for at least two weeks
Key exclusion criteria (13 listed)
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Clinical evidence of extra-central nervous system (CNS) (systemic) non-Hodgkin lymphoma
- Known hypersensitivity to any of the study drugs
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible; patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for >= 2 years prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive AssessmentAncillary studies to evaluate neurocognitive function at study entry and at 2 years after study entry. | Procedure or surgery | Arm I (obinutuzumab, Arm II (observation) |
| ObinutuzumabAlso: Anti-CD20 Monoclonal Antibody R7159, GA-101, GA101, GazyvaGiven IV | Biological | Arm I (obinutuzumab |
| Quality of Life AssessmentAncillary studies to evaluate quality of life at study entry and at 2 years after study entry. | Other | Arm I (obinutuzumab, Arm II (observation) |
Primary outcome
Partial response (PR) or complete response (CR) duration
Time frame: From the date of brain magnetic resonance imaging (MRI) after completion of first-line treatment which confirms PR or CR, to disease progression or death, assessed up to 2 years
PR or CR duration will be assessed using Kaplan-Meier product limit estimates and compared between patients with maintenance versus without obinutuzumab maintenance using the log-rank test. In addition, the Cox proportional hazard model will be used to estimate hazard ratios.
10 secondary outcomes
Overall survival (OS) after CR
Time frame: From the date of brain MRI after completion of first-line treatment which confirms PR or CR, to death, assessed up to 2 years
Neurocognitive function - Wechsler Adult Intelligence Scale
Time frame: Up to 2 years
Quality of life (QOL) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain Neoplasm 20-item
Time frame: Up to 2 years
Progression free survival (PFS)
Time frame: From the start date of first-line primary central nervous system lymphoma (PCNSL) treatment to disease progression or death, assessed up to 2 years
Overall survival
Time frame: From the start date of first-line PCNSL treatment to death, assessed up to 2 years.
Neurocognitive function - Hopkins Verbal Learning Test-Revised
Time frame: Up to 2 years
Neurocognitive function - Grooved Pegboard Test
Time frame: Up to 2 years
Neurocognitive function - Trail Making Test
Time frame: Up to 2 years
Neurocognitive function - Brief Test of Attention
Time frame: Up to 2 years
Quality of life (QOL) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prakash Ambady, MD principal investigator
Providence Health & Services
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Assessment, Obinutuzumab and Quality of Life Assessment in people with Primary Central Nervous System Lymphoma, run by Providence Health & Services at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Gervasi-Follmar (503-216-1023, tiffany.gervasi-follmar@providence.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial response (PR) or complete response (CR) duration (time frame: From the date of brain magnetic resonance imaging (MRI) after completion of first-line treatment which confirms PR or CR, to disease progression or death, assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.