Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma
NCT ID: NCT05334238
Last Updated: 2022-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
174 participants
INTERVENTIONAL
2021-12-01
2025-05-30
Brief Summary
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Detailed Description
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174 patients were enrolled in this study, and randomly divided into Orelabrutinib maintenance group experimental group or observation group (control group) by 1:1. The trial included a screening period (day -28 to day -1), a treatment period (oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation), and a follow-up period (1 year after the end of the last treatment).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Orelabrutinib
oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation
Orelabrutinib
oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation
No Orelabrutinib
no treatment after autologous transplantation
No interventions assigned to this group
Interventions
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Orelabrutinib
oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation
Eligibility Criteria
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Inclusion Criteria
2. Primary CNS lymphoma patients with CR were evaluated in the final stage of first-line therapy, and the virus-infected patients were balanced between the experimental and control groups;
3. Laboratory tests (blood routine, liver and kidney function) meet the following requirements:
A) Blood routine examination: white blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×10\^9/L, hemoglobin ≥90g/L, platelet ≥75×10\^9/L; B) Liver function: transaminase ≤2.5× upper limit of normal value, bilirubin ≤1.5× upper limit of normal value; C) Renal function: serum creatinine 44-133 mmol/L;
4. Participants' ECOG physical status score was 0-2; The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.
Exclusion Criteria
* Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
* Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
1. Neutrophils\<1.5×10\^9/L
2. Platelets\<80×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement)
3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
4. Creatinine is 1.5 times higher than the ULN or eGFR is lower than 40ml/min/1.73m\^2 (according to Cockcroft-Gault Equation or MDRD Equation).
* HIV-infected patients
* Left ventricular ejection fraction\<50%
* Patients with HbsAg positive are required to have HBV DNA\<1.0×10\^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA\<1.0×10\^3 IU/ml is required before entering the group.
* Other anti-tumor treatments (lymphoma or other types of tumors) are currently in progress.
* Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
* History of stroke or intracranial hemorrhage within 6 months prior to start of therapy
* Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
* Other medical conditions determined by the researchers that may affect the study
18 Years
65 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Professor
Locations
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PCNSL-001
Identifier Type: -
Identifier Source: org_study_id
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