Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI

NCT06290817 | Recruiting Phase 2

• 1 other identifier: 2023-0724
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year central nervous system relapse rate

  The proportion of patients with central nervous system recurrence within two years from enrollment accounted for all patients treated with drugs.

  up to 2 years

Secondary Outcomes (7)

• Complete Response Rate

  At the end of Cycle 3 and Cycle 6（each cycle is 21 days）

• Overall Response Rate (ORR)

  At the end of Cycle 3 and Cycle 6（each cycle is 21 days）

• 2-year Overall survival (OS) rate

  Up to 2 years

• 1-year Overall survival (OS) rate

  Up to 1 year

• 2-year progression-free survival (PFS) rate

  2 years after enrollment of final patient

Other Outcomes (1)

• Occurrence of adverse events and serious adverse events according to CTCAE V4.03

  Up to 3 years

Study Arms (1)

Orelabrutinib combined with R-CDOP regimen

EXPERIMENTAL

Participants will receive 150 mg of oral orelabrutinib once daily with R-CDOP on day 1 of each cycle (21 days)

Drug: Orelabrutinib combined with R-CDOP regimen

Interventions

Orelabrutinib combined with R-CDOP regimen DRUG

All participants were treated with the orelabrutinib combined with R-CHOP regimen (O-RCDOP). The treatment plan involved orelabrutinib tablets at 150mg QD (once daily) from day 1 to day 21, Rituximab at 375mg/m2 on day 1; Cyclophosphamide at 750mg/m2 on day 1; Liposomal Doxorubicin at 30mg/m2 on day 0; Vincristine at 25mg/m2 on day 1 (maximum dose 40mg); and Prednisone at 100mg from day 1 to day 5. The treatment cycles were set every 21 days for a total of 6-8 cycles. Dose adjustments were made for elderly patients for Cyclophosphamide and Liposomal Doxorubicin based on age: 70-80% of the dose for those aged 70-80 years old, and 50-60% of the dose for those older than 80 years.

Orelabrutinib combined with R-CDOP regimen

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old; ECOG score 0-3;
• Histologically confirmed diffuse large B-cell lymphoma, including DLBCL and transformed DLBCL;
• CNS-IPI≥4 points
• Previously untreated participants with CD20-positive DLBCL,;
• Heart, liver, and kidney function: creatinine \< 2 times the normal upper limit (ULN); ALT (alanine aminotransferase)/AST (Aspartate Aminotransferase) \< 2.5ULN; Total bilirubin \< 2ULN; Cardiac ejection fraction (EF) ≥50%.
• At least one measurable lesion.
• Have the sufficient understanding ability and voluntarily sign informed consent.

You may not qualify if:

• Patients with evidence of CNS involvement ;
• Clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale, or a history of myocardial infarction within 6 months before screening;
• Human immunodeficiency virus (HIV) infection;
• Pregnant or lactating women;
• Other tumors that require treatment;
• Uncontrolled active infection;
• The HBV DNA copy number of active hepatitis after antiviral treatment can not be controlled within 2×103/ml.
• unable to understand and follow the research protocol or unable to sign the informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• Huizhou Municipal Central Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator

Study Sites (6)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Zhejiang, Zhejiang, China

RECRUITING

Huzhou Central Hospital

Huzhou, China

RECRUITING

Affiliated hospital of Jiaxing University , the First Hospital of Jiaxing

Jiaxing, China

RECRUITING

Affiliated hospital of Jiaxing University , the Second Hospital of Jiaxing

Jiaxing, China

RECRUITING

Ningbo Medical Center LiHuili Hospital

Ningbo, China

RECRUITING

Taizhou Hospital of Zhejiang

Taizhou, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Wenbin Qian

  15.1 Second affiliated hospital， School of Medicine， Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Xibin Xiao

CONTACT

13858015535; xiaoxibinzju@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 4, 2024
• Study Start: March 30, 2023
• Primary Completion: March 30, 2025
• Study Completion: March 20, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

CN (6)