Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

A Multi Center, Randomized, Controlled Clinical Study of the Efficacy and Safety of Orelabrutinib Maintenance Therapy After ASCT in Patients With Primary Central Nervous System Lymphoma

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Central Nervous System Lymphoma
• Intervention / Treatment: Drug: Orelabrutinib

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 lymphoma of the central nervous system in a prospective clinical study.

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).

• Study Type: Interventional
• Enrollment (Anticipated): 174
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ZHAO Weili; Phone Number: 862164370045; Email: zwl_trial@163.com
• Study Contact Backup: Name: XU pengpeng; Phone Number: 862164370045; Email: pengpeng_xu@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20025
      • Recruiting
      • Ruijin Hospital
      • Contact: ZHAO weili; Phone Number: 08664370045; Email: zwl_trial@163.com
      • Contact: XU pengpeng; Phone Number: 08664370045; Email: pengpeng_xu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women, aged 18-65;
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:

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):

  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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orelabrutinib; oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation	Drug: Orelabrutinib; oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation
No Intervention: No Orelabrutinib; no treatment after autologous transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate at 1 years	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.	Baseline up to data cut-off (up to approximately 1 years)
Overall survival at 2 years	Overall survival was defined as the time from the date of randomization to the date of death from any cause.	Baseline up to data cut-off (up to approximately 2 years)

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): May 30, 2025

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Orelabrutinib; Primary Central Nervous System Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: PCNSL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No