Primary Central Nervous System LymphomaPhase 2NCT04899427
Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma
A Phase 2 study testing orelabrutinib, Sintilimab and Tislelizumab in people with Primary Central Nervous System Lymphoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate （ORR） after 4 cycles is the primary endpoint. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- orelabrutinib, Sintilimab and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2021to 24 Oct 2023
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old ≤75 Years old, male or female
- Primary Central nerves system lymphoma confirmed by cytology or histology according to WHO2016 criteria
- No evidence of systemic lymphoma
- Patients with a clear diagnosis of relapsed and/or refractory PCNSL: they received at least one regimen containing methotrexate.
- At least one measurable lesion according to Lugano 2014 criteria
- Adequate organ function and adequate bone marrow reserve
Who cannot join
- Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
- Active HIV, HBV, HCV or treponema pallidum infection
- Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
- Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
- Any systemic antitumor therapy performed within 2 weeks before enrollment
- Previous use of other BTK inhibitors or PD-1 inhibitors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wei Zhang
Beijing, Beijing Municipality, 100730
Wei Zhang, 13681473557, vv1223@vip.sina.com
About this study
Official title: Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma: a Prospective Multi-center Phase II Study
This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate （ORR） after 4 cycles is the primary endpoint.
Read the detailed description
All the patients will be treated with Orelabrutinib combined with PD-1 inhibitor ：Orelabrutinib 150mg qd，Tislelizumab Injection 200mg d1 or Sintilimab injection 200mg d1， every 21-day for 1 cycle). Patients will be evaluated every 2 cycles by MRI scan during the first 6 cycles，and then the interval of investigation will be prolonged to 12 weeks. The patients who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) will receive further treatment. The patients progressed disease (PD) will withdraw from the trial and receive salvage regimens. The treatment will be continued for 2 years or until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
During following-up, surveillance ophthalmologic examination and brain magnetic resonance imaging (MRI) scans can be performed every 3 months up for 2 years.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- orelabrutinib, Sintilimab, Tislelizumab
- Keywords
- Primary Central Nervous System Lymphoma, orelabrutinib, PD-1 inhibitor, Overall response rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orelabrutinibDrug
Orelabrutinib will be given as 150mg per day orally, until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
SintilimabDrug
Sintilimab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
TislelizumabDrug
Tislelizumab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
| Study group | Role | What they receive |
|---|---|---|
| orelabrutinib combined with PD-1 inhibitor | Experimental | The experimental arm will be treated orelabrutinib plus PD-1(programmed death）inhibitor every 21 days as one cycle. The responses will be evaluated every 2 cycles during the first 6 cycles and every 3 months until progression.
The investigators can choose Sintilimab Injection or Tislelizumab Injection at the beginning of treatment，but they can't exchange to another during the whole treatment. Receives: Drug: orelabrutinib; Drug: Sintilimab; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
ORR was calculated by the proportion of patients who achieved complete remission and partial remission.
Measured: 3 weeks after the end of 4 cycles of induction (each cycle is 21 days)
Secondary outcomes (1)
1 years progression-free survival
1 years progression-free survival was calculated from the date of therapy until death from lymphoma or 1-year follow up without relapsing
Measured: from the date of treatment to the subject finished his 1 years follow-up phase or the disease relapsed or the death due to lymphoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start24 Mar 2021
- Primary completion24 Mar 2023 (estimated)
- Study completion24 Oct 2023 (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.
- More trials run by Peking Union Medical College HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Beijing Tongren Hospital, Beijing Luhe Hospital, Shanxi Province Renmin Hospital, Henan Cancer Hospital, Henan Province Renmin Hospital, The Second Affiliated Hospital of Dalian Medical University, Hebei Medical University Fourth Hospital, The First Hospital of Chinese Medical University, Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899427
- Sponsor's protocol ID
- PUMCH-NHL-009
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma: a Prospective Multi-center Phase II Study
- ClinicalTrials.gov ID
- NCT04899427
- Acronym / sponsor ID
- PUMCH-NHL-009
- Conditions
- Primary Central Nervous System Lymphoma
- Keywords
- Primary Central Nervous System Lymphoma, orelabrutinib, PD-1 inhibitor, Overall response rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Beijing Tongren Hospital, Beijing Luhe Hospital, Shanxi Province Renmin Hospital, Henan Cancer Hospital, Henan Province Renmin Hospital, The Second Affiliated Hospital of Dalian Medical University, Hebei Medical University Fourth Hospital, The First Hospital of Chinese Medical University, Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhengzhou University
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 24 Mar 2023 (estimated)
- Study completion
- 24 Oct 2023 (estimated)
- First posted
- 24 May 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.
This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate （ORR） after 4 cycles is the primary endpoint.
Detailed description
All the patients will be treated with Orelabrutinib combined with PD-1 inhibitor ：Orelabrutinib 150mg qd，Tislelizumab Injection 200mg d1 or Sintilimab injection 200mg d1， every 21-day for 1 cycle). Patients will be evaluated every 2 cycles by MRI scan during the first 6 cycles，and then the interval of investigation will be prolonged to 12 weeks. The patients who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) will receive further treatment. The patients progressed disease (PD) will withdraw from the trial and receive salvage regimens. The treatment will be continued for 2 years or until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
During following-up, surveillance ophthalmologic examination and brain magnetic resonance imaging (MRI) scans can be performed every 3 months up for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| orelabrutinib combined with PD-1 inhibitor | Experimental | Drug: orelabrutinib, Drug: Sintilimab, Drug: TislelizumabThe experimental arm will be treated orelabrutinib plus PD-1(programmed death）inhibitor every 21 days as one cycle. The responses will be evaluated every 2 cycles during the first 6 cycles and every 3 months until progression. The investigators can choose Sintilimab Injection or Tislelizumab Injection at the beginning of treatment，but they can't exchange to another during the whole treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old ≤75 Years old, male or female
- Primary Central nerves system lymphoma confirmed by cytology or histology according to WHO2016 criteria
- No evidence of systemic lymphoma
- Patients with a clear diagnosis of relapsed and/or refractory PCNSL: they received at least one regimen containing methotrexate.
- At least one measurable lesion according to Lugano 2014 criteria
Key exclusion criteria (7 listed)
- Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
- Active HIV, HBV, HCV or treponema pallidum infection
- Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
- Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
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 |
|---|---|---|
| orelabrutinibOrelabrutinib will be given as 150mg per day orally, until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. | Drug | orelabrutinib combined with PD-1 inhibitor |
| SintilimabSintilimab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. | Drug | orelabrutinib combined with PD-1 inhibitor |
| TislelizumabTislelizumab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. | Drug | orelabrutinib combined with PD-1 inhibitor |
Primary outcome
overall response rate
Time frame: 3 weeks after the end of 4 cycles of induction (each cycle is 21 days)
ORR was calculated by the proportion of patients who achieved complete remission and partial remission.
1 secondary outcome
1 years progression-free survival
Time frame: from the date of treatment to the subject finished his 1 years follow-up phase or the disease relapsed or the death due to lymphoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing orelabrutinib, Sintilimab and Tislelizumab in people with Primary Central Nervous System Lymphoma, run by Peking Union Medical College Hospital 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 6 inclusion and 7 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 24 May 2021. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 3 weeks after the end of 4 cycles of induction (each cycle is 21 days)). 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 24 May 2021.