Clinical trial NCT05549284: Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Primary Central Nervous System Lymphoma
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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,AST4XULN
* 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.

Primary outcomes:
measure: primary endpoint
timeFrame: Enrollment is expected to last for two year, followed up for five years
Secondary outcomes:
measure: secondary endpoints
timeFrame: Enrollment is expected to last for two year, followed up for five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hospital 307
state: Beijing
Study officials:
References: