Primary Central Nervous System LymphomaPhase 2NCT05390749
Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL
A Phase 2 study testing Orelabrutinib, Pomalidomide and Rituximab in people with Primary Central Nervous System Lymphoma, run by Peking Union Medical College Hospital at 3 sites in China.
Trial summary
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- Orelabrutinib, Pomalidomide and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesChina
- Study dates
- 11 Apr 2022to 1 Apr 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Newly diagnosed primary central nervous system lymphoma
- Pathological type is B cell lymphoma
- Age 18-70 years
- Demonstrate adequate marrow hemopoietic function as defined below:WBC>3.0×109/L,ANC>1.5×109/L,HGB>90g/L,PLT>80×109/L
- Demonstrate adequate organ function as defined below: cardiac function grade 0-2（NYHA）；SpO2>88%( natural state)；ALT<3UNL，TBil<2ULN; SCr>60ml/min/m2
- Having at least one measurable lesions
- Sign the Informed consent
Who cannot join
- • The pathological diagnosis was T-cell lymphoma.
- systemic lymphoma involved CNS
- Pre-existing uncontrolled active infection
- Acute myocardial infarction or unstable angina within 6 months; Uncontrolled hypertension and arrhythmia
- Active bleeding
- Allergic to any component of the investigational product.
- Subjects who are suspected to be unable to comply with the study protocol
- Pregnancy or active lactation
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing TianTan Hospital
Beijing, Beijing Municipality, 100070
Song Lin, +86138 0112 7691, linsong2005@126.com
Song Lin
- Recruiting
Sanbo Brain Hospital Capital Medical University
Beijing, Beijing Municipality, 100500
Shouwei Li, +86150 1133 9604, lishouwei@ccmu.edu.cn
Shouwei Li
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yan Zhang, M.D., +8613810000485, zhangyan10659@pumch.cn
Daobin Zhou
About this study
Official title: Sequential Treatment Regimens With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) as Frontline Therapy for Primary Central Nervous System Lymphoma: a Multicenter Prospective Single Arm Trial
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response [PR] or better) after 4 cycles of POR.
Read the detailed description
There are 2 sections of this trial. Step1: the patients will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study. Step2: Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). After 6 cycles of induction therapy, all patients were followed for survival data every 12 week until disease progression, disease recurrence, death, or study termination. Patients with progression were also followed up for survival data as above. Overall survival will be followed up to 3 years after the last subject entered the study. Establishing the feasibility of chemo-free treatment in primary central nervous system lymphoma will provide the foundation for a larger study of efficacy and long-term outcomes of chemo-free therapy for patients with PCNSL.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- Orelabrutinib, Pomalidomide, Rituximab, Methotrexate
- Keywords
- Orelabrutinib, Pomalidomide, Rituximab, primary central nervous system lymphoma, methotrexate
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 orally d1-d21 for 6 cycles,every 21 days for 1 cycle.
PomalidomideDrug
Pomalidomide will be given as 4mg d1-d14 for 4 cycles,every 21 days for 1 cycle.
RituximabDrug
Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
MethotrexateDrug
methotrexate 3.5g/m2 civ d1/cycle5-6
| Study group | Role | What they receive |
|---|---|---|
| POR-ROMTX | Experimental | The experimental arm will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study.Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). Receives: Drug: Orelabrutinib; Drug: Pomalidomide; Drug: Rituximab; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
ORR is defined as the proportion of patients with a best response of CR, CRu or PR
Measured: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days
Secondary outcomes (5)
overall response rate
ORR is defined as the proportion of patients with a best response of CR, CRu or PR
Measured: The ORR will be evaluated at 126 days from date of signing the informed consent , which means after 6 cycles and each cycle is 21 days
complete response rate
CR is defined as the proportion of patients with a best response of CR or CRu
Measured: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days
2 years progression-free survival
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
Measured: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2 years overall survival
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive
Measured: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
The occurrence of adverse events and serious adverse events
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Measured: during follow-up, 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 posted25 May 2022
- Study start11 Apr 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2026 (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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Capital Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390749
- Sponsor's protocol ID
- PUMCH-NHL-013
- Status last verified
- Apr 2022
- First submitted
- 11 May 2022
- Last updated
- 25 May 2022
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Treatment Regimens With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) as Frontline Therapy for Primary Central Nervous System Lymphoma: a Multicenter Prospective Single Arm Trial
- ClinicalTrials.gov ID
- NCT05390749
- Acronym / sponsor ID
- PUMCH-NHL-013
- Conditions
- Primary Central Nervous System Lymphoma
- Keywords
- Orelabrutinib, Pomalidomide, Rituximab, primary central nervous system lymphoma, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Capital Medical University
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 25 May 2022 (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 multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response [PR] or better) after 4 cycles of POR.
Detailed description
There are 2 sections of this trial. Step1: the patients will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study. Step2: Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). After 6 cycles of induction therapy, all patients were followed for survival data every 12 week until disease progression, disease recurrence, death, or study termination. Patients with progression were also followed up for survival data as above. Overall survival will be followed up to 3 years after the last subject entered the study. Establishing the feasibility of chemo-free treatment in primary central nervous system lymphoma will provide the foundation for a larger study of efficacy and long-term outcomes of chemo-free therapy for patients with PCNSL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POR-ROMTX | Experimental | Drug: Orelabrutinib, Drug: Pomalidomide, Drug: Rituximab, Drug: MethotrexateThe experimental arm will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study.Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Newly diagnosed primary central nervous system lymphoma
Key exclusion criteria (8 listed)
- • The pathological diagnosis was T-cell lymphoma.
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 orally d1-d21 for 6 cycles,every 21 days for 1 cycle. | Drug | POR-ROMTX |
| PomalidomidePomalidomide will be given as 4mg d1-d14 for 4 cycles,every 21 days for 1 cycle. | Drug | POR-ROMTX |
| RituximabRituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol | Drug | POR-ROMTX |
| Methotrexatemethotrexate 3.5g/m2 civ d1/cycle5-6 | Drug | POR-ROMTX |
Primary outcome
overall response rate
Time frame: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days
ORR is defined as the proportion of patients with a best response of CR, CRu or PR
5 secondary outcomes
overall response rate
Time frame: The ORR will be evaluated at 126 days from date of signing the informed consent , which means after 6 cycles and each cycle is 21 days
complete response rate
Time frame: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days
2 years progression-free survival
Time frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2 years overall survival
Time frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years
The occurrence of adverse events and serious adverse events
Time frame: during follow-up, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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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.
3 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 Orelabrutinib, Pomalidomide and Rituximab in people with Primary Central Nervous System Lymphoma, run by Peking Union Medical College Hospital at 3 sites 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 7 inclusion and 8 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Yan Zhang, M.D. (+8613810000485, zhangyan10659@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and 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 25 May 2022.