Prospective, Multicenter, Single-arm Clinical Study of Orelabrutinib Plus Rituximab for Second-line Treatment of Relapsed/Refractory Marginal Zone Lymphoma

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age: 18 years, 80, Sex gender no limitied;

• histological confirmation of MZL, For splenic marginal zone lymphoma (SMZL) where histological specimens of the spleen were not available, Requirements to meet the minimum diagnostic criteria for SMZL, And exclude any other type of small B cell lymphoma, That is, requiring a definite diagnosis of MZL;

• at least one two-dimensional measurable lymph node lesion (CT scan or MR / display maximum diameter\> 1.5cm), Or at least one two-dimensional measurable extranodal lesion (CT scan or MRI showing maximum diameter\> 1.0cm);

• the investigator required systemic treatment for marginal zone lymphoma;

• at least 1 previous course of systemic lymphoma treatment (including previous immunotherapy or chemoimmunotherapy), 3 without efficacy above PR after imaging evaluation, Or disease progression after effective treatment;

• ECOG, physical strength score 0-2;

• primary organ function meets the following criteria 7 days prior to treatment:

∙ blood routine: absolute neutrophil ≥1.5x10\^9 / L, Platelet≥ 75x10\^9 / L, Hemoglobin≥75g / L; If the concomitant bone marrow invasion, Absolute neutrophil value ≥1.0x10\^9 / L, Platelet≥50x10\^9 / L, Hemoglobin≥ 50g / L;

‣ Blood Chemistry: total bilirubin ≤1.5 times ULN, AST or ALT ≤2 times ULN; If the liver is infiltrated with a lymphoma, Then, ALT and AST ≤5 times ULN, Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥45 ml/min (Cockcroft-Gault formula); Serum amylase ≤ULN;

‣ coagulation function: International normalized ratio (INR) ≤1.5 times ULN, Activated partial thromboplastin time (APTT)≤ 1.5 times ULN.

‣ cardiac color ultrasound: left ventricular ejection fraction 50%;

• expected survival time of 3 months;

• for men who did not undergo sterilization: agree to use the barrier contraceptive method during treatment and for at least 3 months after the last administration of obutinib or rituximab or on the older) as required in the guidelines established by the institution. In addition, male patients must agree to request their spouses to use other methods of contraception (e. g., oral contraceptives, intrauterine devices, barrier contraception, or spermicide).

⁃ For women who did not undergo sterilization: at least 28 days prior to consent to start study medication, during treatment, or after last administration of obutinib or rituximab, such as oral contraceptives, intrauterine devices or barrier contraception;

⁃ voluntarily signed written informed consent before test screening.

Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital
RECRUITING
Hangzhou
86-574-87085596
RECRUITING
Ningbo
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Contact Information
Primary
Lixia Sheng, Doctor
slx800408@163.com
86-574-87085596
Backup
Chen
nbyykyk@163.com
86-574-87085111
Time Frame
Start Date: 2023-01-02
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 39
Treatments
Experimental: OR regimen
The specific medication regimen for the OR regimen is as follows: Orelabrutinib 150mg orally once daily; Rituximab 375mg/m² intravenous infusion, administered every 21 days.
Related Therapeutic Areas
Sponsors
Leads: Lixia Sheng

This content was sourced from clinicaltrials.gov