Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and safety for newly diagnosed Marginal zone cell lymphoma

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

• Age: ≥18 years old, gender is not limited;

• Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL;

• Indications for treatment: impact on organ function, development of symptoms associated with lymphoma, large masses, hematopenia secondary to lymphoma;

• MZL that has progressed, relapsed, or is unsuitable for local therapy after prior local therapy (local therapy includes surgery, radiotherapy, anti-Helicobacter pylori therapy, anti-hepatitis C therapy);

• ECOG 0-2;

• Must have at least one measurable or evaluable lesion using the Lugano 2014 Lymphoma Efficacy Evaluation Criteria: i.e., PET/CT with an evaluable lesion; an intranodal lesion with a long diameter greater than 1.5 cm and a short diameter greater than 1.0 cm or an extranodal lesion with a long diameter of \> 1.0 cm, as assessed by CT or MR

• Participants with splenic MZL who do not meet the above criteria for radiologically measurable disease are eligible, provided that the bone marrow infiltration of the MZL is histologically confirmed;

• HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) are eligible for enrollment only if they have a negative HBV-DNA test;

• Major organ function meets the following criteria: a) Blood routine: absolute neutrophil value ≥1.5×109/L, platelet ≥75×109/L, hemoglobin ≥75g/L; if accompanied by bone marrow invasion, absolute neutrophil value ≥1.0×109/L, platelet ≥50×109/L, hemoglobin ≥50g/L; b) Blood biochemistry: total bilirubin ≤1.5 times the ULN, AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN; c) Coagulation function: International Normalized Ratio (INR) ≤ 1.5 times ULN. 10) Expected survival ≥ 3 months;

⁃ Voluntary written informed consent prior to trial screening.

Locations
Other Locations
China
Bing, Xu
RECRUITING
Xiamen
Contact Information
Primary
Bing Xu, PhD
xubingzhangjian@126.com
18750918842
Time Frame
Start Date: 2024-06-23
Estimated Completion Date: 2027-06-23
Participants
Target number of participants: 36
Treatments
Experimental: OR
Orelabrutinib in combination with rituximab
Related Therapeutic Areas
Sponsors
Collaborators: Jiangxi Provincial Cancer Hospital, Nanfang Hospital, Southern Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Second Affiliated Hospital of Dalian Medical University, Guangdong Provincial People's Hospital, Shaanxi Provincial Cancer Hospital, The First Hospital of Jilin University, Chinese PLA General Hospital, Fujian Cancer Hospital
Leads: The First Affiliated Hospital of Xiamen University

This content was sourced from clinicaltrials.gov