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Trial Title:
Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)
NCT ID:
NCT05549284
Condition:
Primary Central Nervous System Lymphoma
Conditions: Official terms:
Lymphoma
Rituximab
Methotrexate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib,Rituximab and Methotrexate
Description:
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.
Arm group label:
Orelabrutinib,Rituximab and Methotrexate
Other name:
RMO
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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,A
ST4XULN
- The expected survival time is at least 3 months
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital 307
Address:
City:
Beijing
Zip:
100071
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenrong Huang, Dr.
Phone:
861066947169
Email:
huangwr301@163.com
Contact backup:
Last name:
shihua zhao, Dr.
Phone:
861066947167
Email:
zhaoshihua307@163.com
Start date:
June 1, 2022
Completion date:
May 30, 2026
Lead sponsor:
Agency:
Affiliated Hospital to Academy of Military Medical Sciences
Agency class:
Other
Source:
Affiliated Hospital to Academy of Military Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05549284
