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Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

Primary Purpose

Primary Central Nervous System Lymphoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Orelabrutinib

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma focused on measuring Primary Central Nervous System Lymphoma, Orelabrutinib

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 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

Sites / Locations

Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Orelabrutinib

No Orelabrutinib

Arm Description

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

no treatment after autologous transplantation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05334238

First Posted

January 10, 2022

Last Updated

April 18, 2022

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05334238

Brief Title

Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Central Nervous System Lymphoma

Keywords

Primary Central Nervous System Lymphoma, Orelabrutinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Orelabrutinib

Arm Type

Experimental

Arm Description

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

Arm Title

No Orelabrutinib

Arm Type

No Intervention

Arm Description

no treatment after autologous transplantation

Intervention Type

Drug

Intervention Name(s)

Orelabrutinib

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival at 2 years

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Complete response rate at 1 years

Description

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Time Frame

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

Title

Overall survival at 2 years

Description

Overall survival was defined as the time from the date of randomization to the date of death from any cause.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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): 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ZHAO Weili

Phone

862164370045

zwl_trial@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

XU pengpeng

Phone

862164370045

pengpeng_xu@126.com

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

20025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ZHAO weili

Phone

08664370045

zwl_trial@163.com

First Name & Middle Initial & Last Name & Degree

XU pengpeng

Phone

08664370045

pengpeng_xu@126.com

12. IPD Sharing Statement

Plan to Share IPD

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Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

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