Refractory Central Nervous System LymphomaNCT04845139
A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
A study testing Nivolumab in people with Refractory Central Nervous System Lymphoma and Relapsed Primary Central Nervous System Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to determine whether Nivolumab given intrathecally is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Refractory Central Nervous System Lymphoma, Relapsed Primary Central Nervous System Lymphoma, Primary Central Nervous System Lymphoma
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with ECOG 0,1,2,3
- Subjects with pathologically confirmed PCNSL with lesion in brain who progressed after or did not respond to at least 1 line of systemic therapy. PCNSL prior therapy may include HD-MTX, HD-MTX-based regimen, high-dose cytarabine, radiation therapy alone as treatment or as part of consolidation therapy, high-dose therapy with autologous stem cell transplant as part of consolidation therapy, and/or intraocular MTX alone or as part of consolidation therapy
- Subject with sufficient function of liver, kidney, heart, lung and hematopoiesis
- Subjects with relapsed PCNSL and are able to receive biopsy
Who cannot join
- Subjects that are not DLBCL type pathologically
- Intraocular PCNSL without evidence of brain disease
- Subjects who cannot undergo MRI assessments
- Relapsed PCNSL patients who cannot undergo biopsy
- Biopsy suggests no significant tumor-infiltration T cell or poor PD-1 expression
- Subjects with other malignancy
Show all 11Show fewer
- Subjects with history of any inflammatory CNS diseases
- Subjects with an active, known, or suspected autoimmune disease
- Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether Nivolumab given intrathecally is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Read the detailed description
This is a case study aiming to recruit 1 patient. This study is indicated for relapsed/refractory primary central nervous system lymphoma. Primary objective is to explore the safety.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called NIVO；Opdivo; BMS-936558
Nivolumab given intraventricularly
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab administration | Experimental | Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: On a continuous basis up to 1 month after the first dose of study drug
Secondary outcomes (1)
Best overall response(BOR)
Record individual best overall response(BOR), including CR, PR, SD, PD
Measured: up to 3 months after the first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start2 Jul 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianmin Zhang, M.D., Principal investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845139
- Sponsor's protocol ID
- 2021-0139
- Status last verified
- Jul 2022
- First submitted
- 11 Apr 2021
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT04845139
- Acronym / sponsor ID
- 2021-0139
- Conditions
- Refractory Central Nervous System Lymphoma, Relapsed Primary Central Nervous System Lymphoma, Primary Central Nervous System Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 2 Jul 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 14 Apr 2021 (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.
The purpose of this study is to determine whether Nivolumab given intrathecally is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Detailed description
This is a case study aiming to recruit 1 patient. This study is indicated for relapsed/refractory primary central nervous system lymphoma. Primary objective is to explore the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab administration | Experimental | Drug: NivolumabNivolumab administration Q2W by intraventricular injection through Ommaya reservoir |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with ECOG 0,1,2,3
- Subjects with pathologically confirmed PCNSL with lesion in brain who progressed after or did not respond to at least 1 line of systemic therapy. PCNSL prior therapy may include HD-MTX, HD-MTX-based regimen, high-dose cytarabine, radiation therapy alone as treatment or as part of consolidation therapy, high-dose therapy with autologous stem cell transplant as part of consolidation therapy, and/or intraocular MTX alone or as part of consolidation therapy
- Subject with sufficient function of liver, kidney, heart, lung and hematopoiesis
- Subjects with relapsed PCNSL and are able to receive biopsy
Key exclusion criteria (11 listed)
- Subjects that are not DLBCL type pathologically
- Intraocular PCNSL without evidence of brain disease
- Subjects who cannot undergo MRI assessments
- Relapsed PCNSL patients who cannot undergo biopsy
- Biopsy suggests no significant tumor-infiltration T cell or poor PD-1 expression
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 |
|---|---|---|
| NivolumabAlso: NIVO；Opdivo; BMS-936558Nivolumab given intraventricularly | Drug | Nivolumab administration |
Primary outcome
Adverse events
Time frame: On a continuous basis up to 1 month after the first dose of study drug
Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria
1 secondary outcome
Best overall response(BOR)
Time frame: up to 3 months after the first dose of study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- 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. This study is not recruiting at the moment.
Jianmin Zhang, M.D. principal investigator
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nivolumab in people with Refractory Central Nervous System Lymphoma and Relapsed Primary Central Nervous System Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: On a continuous basis up to 1 month after the first dose of study drug). 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 7 Jul 2022.