Trial Title:
Clinical Study of OR for Second-line Treatment of Refractory MZL
NCT ID:
NCT06134284
Condition:
OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Rituximab
Study type:
Interventional
Study phase:
Phase 4
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 combined with rituximab
Description:
This is a single-arm trial. Patients with relapsed/refractory marginal zone lymphoma will
be treated with the OR regimen. The treatment plan is as follows: Orelabrutinib 150mg
oral administration once a day, Day 1-21; Rituximab 375mg/m² intravenous infusion, Day 1.
Each cycle is 21 days. PET-CT evaluation will be conducted after 4 cycles. If a partial
response (PR) or better is achieved, the patient will receive further treatment with the
OR regimen for an additional 4 cycles before transitioning to single-agent maintenance
therapy with either rituximab or obinutuzumab. If a PR or better is not achieved after 4
cycles, the patient will discontinue from the trial.
Arm group label:
OR regimen
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18 years, 80, Sex gender no limitied;
2. 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;
3. 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);
4. the investigator required systemic treatment for marginal zone lymphoma;
5. 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;
6. ECOG, physical strength score 0-2;
7. primary organ function meets the following criteria 7 days prior to treatment:
1. 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;
2. 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;
3. coagulation function: International normalized ratio (INR) ≤1.5 times ULN,
Activated partial thromboplastin time (APTT)≤ 1.5 times ULN.
4. cardiac color ultrasound: left ventricular ejection fraction 50%;
8. expected survival time of 3 months;
9. 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).
10. 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;
11. voluntarily signed written informed consent before test screening.
Exclusion Criteria:
1. The patient had been previously treated with obutinib in combination with rituximab,
Efficacy was assessed as being refractory, Infraciness was defined as no remission
(PR or CR) after start of treatment 4
2. history of severe allergy or allergic reaction to monoclonal antibody therapy
3. known to be allergic to any study drug
4. current or previous other malignancy, Unless curative treatment with no evidence of
recurrence and metastasis in nearly 5 years;
5. lymphoma involvement of the central nervous system;
6. uncontrolled or important cardiovascular disease, Includes:
1. occurrence of New York Cardiology Association (NYHA) grade II or above
congestive heart failure, unstable angina, myocardial infarction within 6
months prior to the first administration of study drug, Or the presence of
significant arrhythmias requiring treatment at screening (e. g., persistent
rapid AF, persistent ventricular tachycardia, ventricular fibrillation, tip
torsion, history of second-degree II AV (AV) block, or history of third-degree
AV block), Left ventricular ejection fraction (LVEF) <50%;
2. primary cardiomyopathy (e. g. dilated cardiomyopathy, hypertrophic
cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive
cardiomyopathy, irregular cardiomyopathy);
3. history of clinically significant QTc interval extension, Or subjects with
coronary heart disease with QTc interval female> 470ms and male> 450ms;
4. symptomatic or requiring medication;
5. difficult-to-control hypertension (on the basis of improved lifestyle, With an
adequate amount of 2 or more antihypertensive drugs (including diuretics) for
more than 1 month, Or take 4 or more antihypertensive drugs to effectively
control blood pressure).
7. Active bleeding within the 2 months prior to screening, Or are taking anticoagulant
drugs, Or if the investigator considers a definite bleeding tendency;
8. urine protein 2 +, And 24-hour urinary protein quantification of 2g / 24 hours;
9. a history of deep vein thrombosis or pulmonary embolism;
10. clinically obvious gastrointestinal abnormalities, May affect drug intake,
transport, or absorption (e. g. inability to swallow, chronic diarrhea, intestinal
obstruction, etc.), Or subjects with total gastrectomy;
11. history of organ transplantation or allogeneic bone marrow transplantation;
12. major surgery within 6 weeks or minor surgery within 2 weeks before screening. Major
surgery is using general anesthesia, but diagnostic endoscopy is not considered a
major surgical procedure. The insertion of a vascular access device will be exempted
from this exclusion criteria;
13. active infection or uncontrolled HBV (HBV DNA titer of 10 ^ 3 copies / ml), HCVAb
positive, HI V/A IDS (Acquired Immune Deficiency Syndrome) or other serious
infectious diseases;
14. subjects with current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis,
radiation pneumonitis, drug-related pneumonia, severe impairment of lung function,
etc.;
15. Previous treatment with BTK, BCR, pathway inhibitors (such as PI3K, Syk), and BCL-2
kinase inhibitors;
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin Qian, Doctor
Phone:
86-571-87581969
Email:
qianwb@zju.edu.cn
Facility:
Name:
86-574-87085596
Address:
City:
Ningbo
Zip:
315010
Country:
China
Status:
Recruiting
Contact:
Last name:
Lixia Sheng, doctor
Phone:
86-574-87085596
Email:
slx800408@163.com
Facility:
Name:
The First Affiliated Hospital of Ningbo University
Address:
City:
Ningbo
Zip:
315010
Country:
China
Status:
Recruiting
Contact:
Last name:
Lixia Sheng, doctor
Phone:
86-574-87085596
Email:
slx800408@163.com
Start date:
January 2, 2023
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Lixia Sheng
Agency class:
Other
Source:
Ningbo No. 1 Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06134284
