Status:
UNKNOWN
Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma
Lead Sponsor:
Ruijin Hospital
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A multicenter, randomized, prospective clinical study of the efficacy and safety of Orelabrutinib maintenance therapy after Autologous Stem Cell Transplantation (ASCT) in patients with primary central...
Detailed Description
This trial was designed as a multicenter, randomized controlled, prospective clinical study. To evaluate the efficacy and safety of Orelabrutinib maintenance therapy with ASCT in patients with primary...
Eligibility Criteria
Inclusion
- Men and women, aged 18-65;
- 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;
- 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;
- 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
- Presence of any of the following criteria will exclude a patient from enrollment:
- 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):
- Neutrophils\<1.5×10\^9/L
- Platelets\<80×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement)
- 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.
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT05334238
Start Date
December 1 2021
End Date
May 30 2025
Last Update
April 19 2022
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 20025