Primary Central Nervous System LymphomaPhase 2RMONCT05549284
Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)
A Phase 2 study testing Orelabrutinib,Rituximab and Methotrexate in people with Primary Central Nervous System Lymphoma, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
This is a prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(PCNSL).Objective response and… 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,Rituximab and Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 May 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
- primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy;
- Aged 18-70 years
- Signature of informed consent;
- At least one measurable lesion;
- Neutropile≥1.5X109/L,Hemoglobin≥80g/L,Platelets≥75X109/L,Billrubin<2XULN,ALT<4XULN,AST4XULN
- The expected survival time is at least 3 months
Who cannot join
- Those who have contraindications to any of the components in the Orelabrutinib,Rituximab and HD-MTX
- History of other malignancies that may affect the compliance of the research protocol or the analysis of the results
- Severe cardiac insufficiency
- Other antitumor treatments were used
- Human immunodeficiency virus(HIV)antibody is positive
- Pregnant or lactating women
- Researchers consider if anyone not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital 307
Beijing, Beijing Municipality, 100071
Wenrong Huang, Dr., 861066947169, huangwr301@163.com
shihua zhao, Dr., 861066947167, zhaoshihua307@163.com
About this study
Official title: a Single Arm,Multi-center,Phase II Clinical Trial of Combined Therapy for Orelabrutinib,Rituximab and Methotrexate(RMO)in Newly-diagnosed Primary Center Nervous System Lymphoma(PCNSL)
This is a prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(PCNSL).Objective response and complete response are the primary endpoint.
Read the detailed description
This is a single-arm,multicenter,phase 2 study to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma.The response will be evaluated every 2 cycles.Patients who achieved complete remission(CR) or partial remission(PR) will receive further treatment,and there are 6 cycles of RMO regimen for the induction.The patients with stable disease(SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens.After total 6 induction cycles,the investigators evaluate the efficiency again.After 6 cycles,the patients who receive CR or PR,can tolerate Autologous Hematopoietic Stem Cell Transplantation(AHSCT) will be candidates of high-dose chemotherapy and stem rescue.The patients who achieve CR or PR,cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance.The patients with SD or PD will receive salvage regimen.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- Orelabrutinib,Rituximab and Methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib,Rituximab and MethotrexateDrug
Also called RMO
Orelabrutinib, Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma. The response will be evaluated every 2 cycles. Patients who achieved complete remission (CR) or partial remission (PR) will receive further treatment, and there are 6 cycles of RMO regimen for the induction. The patients with stable disease (SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens. After total 6 induction cycles, the investigators evaluate the efficiency again. After 6 cycles, the patients who receive CR or PR, can tolerate Autologous Hematopoietic Stem Cell Transplantation (AHSCT) will be candidates of high-dose chemotherapy and stem rescue. The patients who achieve CR or PR, cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance. The patients with SD or PD will receive salvage regimen.
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib,Rituximab and Methotrexate | Experimental | Rituximab 375 mg/m2 d1; MTX 3.5mg/m2,d2; Orelabrutinib 150g/day; every three week/cycle. Receives: Drug: Orelabrutinib,Rituximab and Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary endpoint
Objective response rate(ORR) is the primary endpoint
Measured: Enrollment is expected to last for two year, followed up for five years
Secondary outcomes (1)
secondary endpoints
Complete rate(CR)、progression free survival(PFS)、overall survival(OS) are the secondary endpoints
Measured: Enrollment is expected to last for two year, followed up for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Jun 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 May 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.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549284
- Sponsor's protocol ID
- 307-947168-88
- Acronym
- RMO
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 22 Sep 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 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Single Arm,Multi-center,Phase II Clinical Trial of Combined Therapy for Orelabrutinib,Rituximab and Methotrexate(RMO)in Newly-diagnosed Primary Center Nervous System Lymphoma(PCNSL)
- ClinicalTrials.gov ID
- NCT05549284
- Acronym / sponsor ID
- RMO / 307-947168-88
- Conditions
- Primary Central Nervous System Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 22 Sep 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 prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(PCNSL).Objective response and complete response are the primary endpoint.
Detailed description
This is a single-arm,multicenter,phase 2 study to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma.The response will be evaluated every 2 cycles.Patients who achieved complete remission(CR) or partial remission(PR) will receive further treatment,and there are 6 cycles of RMO regimen for the induction.The patients with stable disease(SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens.After total 6 induction cycles,the investigators evaluate the efficiency again.After 6 cycles,the patients who receive CR or PR,can tolerate Autologous Hematopoietic Stem Cell Transplantation(AHSCT) will be candidates of high-dose chemotherapy and stem rescue.The patients who achieve CR or PR,cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance.The patients with SD or PD will receive salvage regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib,Rituximab and Methotrexate | Experimental | Drug: Orelabrutinib,Rituximab and MethotrexateRituximab 375 mg/m2 d1; MTX 3.5mg/m2,d2; Orelabrutinib 150g/day; every three week/cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy;
- Aged 18-70 years
- Signature of informed consent;
- At least one measurable lesion;
- Neutropile≥1.5X109/L,Hemoglobin≥80g/L,Platelets≥75X109/L,Billrubin<2XULN,ALT<4XULN,AST4XULN
Key exclusion criteria (7 listed)
- Those who have contraindications to any of the components in the Orelabrutinib,Rituximab and HD-MTX
- History of other malignancies that may affect the compliance of the research protocol or the analysis of the results
- Severe cardiac insufficiency
- Other antitumor treatments were used
- Human immunodeficiency virus(HIV)antibody is positive
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 |
|---|---|---|
| Orelabrutinib,Rituximab and MethotrexateAlso: RMOOrelabrutinib, Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma. The response will be evaluated every 2 cycles. Patients who achieved complete remission (CR) or partial remission (PR) will receive further treatment, and there are 6 cycles of RMO regimen for the induction. The patients with stable disease (SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens. After total 6 induction cycles, the investigators evaluate the efficiency again. After 6 cycles, the patients who receive CR or PR, can tolerate Autologous Hematopoietic Stem Cell Transplantation (AHSCT) will be candidates of high-dose chemotherapy and stem rescue. The patients who achieve CR or PR, cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance. The patients with SD or PD will receive salvage regimen. | Drug | Orelabrutinib,Rituximab and Methotrexate |
Primary outcome
primary endpoint
Time frame: Enrollment is expected to last for two year, followed up for five years
Objective response rate(ORR) is the primary endpoint
1 secondary outcome
secondary endpoints
Time frame: Enrollment is expected to last for two year, followed up for five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 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.
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,Rituximab and Methotrexate in people with Primary Central Nervous System Lymphoma, run by Affiliated Hospital to Academy of Military Medical Sciences 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 22 Sep 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.
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 wenrong huang, Dr (861066947177, huangwr301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary endpoint (time frame: Enrollment is expected to last for two year, followed up for five 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 22 Sep 2022.