Trial Title:
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy
NCT ID:
NCT06478472
Condition:
Marginal Zone Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Rituximab
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib in combination with rituximab
Description:
Induction Phase:
Orelabrutinib + rituximab for a total of 6 cycles of 28 days each Obrutinib (O) 150mg
oral d1-28 Rituximab (R) 375mg/m2 IV d0
Maintenance phase:
Orelabrutinib 150mg po qd 24 cycles of 28 days each
Arm group label:
OR
Summary:
Orelabrutinib combined with rituximab (OR) therapy were used to assess the efficacy and
safety for newly diagnosed Marginal zone cell lymphoma
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: ≥18 years old, gender is not limited;
2. Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT,
SMZL, NMZL;
3. Indications for treatment: impact on organ function, development of symptoms
associated with lymphoma, large masses, hematopenia secondary to lymphoma;
4. 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);
5. ECOG 0-2;
6. 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
7. 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;
8. HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) are
eligible for enrollment only if they have a negative HBV-DNA test;
9. 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;
10. Voluntary written informed consent prior to trial screening.
Exclusion Criteria:
1. Lymphoma with CNS involvement or high grade transformation;
2. HIV-positive patients and or HCV-active infection (documented by HCV-RNA-positive
test);
3. History of deep vein thrombosis or pulmonary embolism within the last 6 months;
4. Active bleeding within 2 months prior to screening, or taking anticoagulant
medications, or in the opinion of the investigator, a definite bleeding tendency
5. Continuous use of drugs with moderate to severe inhibition or strong induction of
cytochrome P450 CYP3A;
6. Severe chronic obstructive pulmonary disease (COPD) with hypoxemia.
7. Active bacterial, fungal, or viral infections uncontrolled by systemic therapy;
8. In addition to cured basal cell carcinoma of the skin or cervical cancer in situ or
early prostate cancer not requiring systemic therapy, or early breast cancer
requiring surgery alone. Other malignant tumors within the last 2 years or
concurrently;
9. Uncontrolled or significant cardiovascular disease, including: a) New York Heart
Association (NYHA) Class II or higher congestive heart failure, unstable angina,
myocardial infarction within 6 months prior to the first dose of study drug, or an
arrhythmia requiring treatment with a left ventricular ejection fraction (LVEF) of
<50% at the time of Screening; b) primary cardiomyopathies (e.g., dilated
cardiomyopathy, hypertrophic cardiomyopathy, hypertrophic cardiomyopathy,
cardiomyopathy, cardiomyopathy, cardiomyopathy, cardiomegaly, cardiomyopathy,
cardiomegaly) b) Primary cardiomyopathies (e.g., dilated cardiomyopathy,
hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy,
restrictive cardiomyopathy, indeterminate cardiomyopathy); c) A history of
clinically significant prolongation of the QTc interval, or QTc intervals of >470 ms
in women and >450 ms in men at Screening; d) Subjects with symptomatic or
medically-treated coronary artery heart disease; e) Subjects with
difficult-to-control high blood pressure (as determined by a reasonable and
tolerable dose of adequate medications based on lifestyle improvement). (blood
pressure remains uncontrolled for more than 1 month despite the application of a
reasonably tolerable and adequate dose of 3 or more antihypertensive medications
(including diuretics) on the basis of lifestyle improvement, or blood pressure is
not effectively controlled until 4 or more antihypertensive medications have been
administered);
10. Subjects with clinically significant gastrointestinal abnormalities that may
interfere with drug ingestion, transit, or absorption (e.g., inability to swallow,
chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy;
11. Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks
prior to screening. A major surgical procedure is one in which general anesthesia is
used, but endoscopy for diagnostic purposes is not considered a major surgical
procedure. Insertion of vascular access devices will be exempt from this exclusion
criterion; ;
12. Subjects who use drugs or alcohol;
13. Pregnant, lactating females and subjects of childbearing age who do not wish to use
contraception;
14. known hypersensitivity or allergic reaction to murine antibodies or proteins
15. Any mental or cognitive impairment that may limit understanding, implementation, and
compliance with the informed consent form;
16. Previous treatment with BTK, BCR pathway inhibitors (e.g., PI3K, Syk), and BCL-2
inhibitors.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bing, Xu
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Xu
Start date:
June 23, 2024
Completion date:
June 23, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Collaborator:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Dalian Medical University
Agency class:
Other
Collaborator:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Shanxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06478472
