Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

NCT05334238 | Unknown Phase 3 DMC

• 1 other identifier: PCNSL-001
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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 nervous system lymphoma.

Conditions

Primary Central Nervous System Lymphoma

Keywords

Primary Central Nervous System Lymphoma; Orelabrutinib

Outcome Measures

Primary Outcomes (1)

• Progression free survival at 2 years

  Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

  Baseline up to data cut-off (up to approximately 2 years)

Secondary Outcomes (2)

• Complete response rate at 1 years

  Baseline up to data cut-off (up to approximately 1 years)

• Overall survival at 2 years

  Baseline up to data cut-off (up to approximately 2 years)

Study Arms (2)

Orelabrutinib

EXPERIMENTAL

oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation

Drug: Orelabrutinib

No Orelabrutinib

NO INTERVENTION

no treatment after autologous transplantation

Interventions

Orelabrutinib DRUG

oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation

Orelabrutinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 20025, China

RECRUITING

MeSH Terms

Interventions

orelabrutinib

Central Study Contacts

ZHAO Weili

CONTACT

862164370045; zwl_trial@163.com

XU pengpeng

CONTACT

862164370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: April 19, 2022
• Study Start: December 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2025
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)