To hear about similar clinical trials, please enter your email below
Trial Title:
Zanubrutinib Plus Rituximab As Front-line Treatment for Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
NCT ID:
NCT06647732
Condition:
Mucosa-associated Lymphoid Tissue Lymphoma (MALT)
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Rituximab
Zanubrutinib
Study type:
Interventional
Study phase:
Phase 2
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:
Zanubrutinib
Description:
160 mg, administered twice daily from Day 1 to Day 28 (D1-D28)
Arm group label:
Zanubrutinib in combination with Rituximab
Intervention type:
Drug
Intervention name:
Rituximab
Description:
375 mg/m², administered once a week during Cycle 1 (C1), and on Day 1 (D1) of Cycles 2-6
(C2-C6)
Arm group label:
Zanubrutinib in combination with Rituximab
Summary:
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the
efficacy and safety of Zanubrutinib in combination with Rituximab as a first-line
treatment for patients with mucosa-associated lymphoid tissue (MALT) extranodal marginal
zone lymphoma.
Detailed description:
The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib in
combination with Rituximab as a first-line treatment for patients with mucosa-associated
lymphoid tissue (MALT) extranodal marginal zone lymphoma.
Treatrment:
1. Rituximab: 375 mg/m², administered once a week in Cycle 1 (C1) and on Day 1 (D1) of
Cycles 2-6 (C2-C6).
2. Zanubrutinib: 160 mg, administered twice daily from Day 1 to Day 28 (D1-D28). Each
cycle lasts 28 days. After 6 cycles of treatment, patients who achieve complete
remission (CR) will end treatment and enter observation follow-up. Patients with
partial remission (PR) or stable disease (SD) will receive 2 additional cycles.
The primary study endpoint is the complete remission rate of Zanubrutinib in combination
with Rituximab in the treatment of newly diagnosed mucosa-associated lymphoid tissue
(MALT) extranodal marginal zone lymphoma.
Criteria for eligibility:
Criteria:
Key inclusion Criteria:
1. Mucosa-associated lymphoid tissue (MALT) extranodal marginal zone lymphoma confirmed
by histopathology.
2. Newly diagnosed with Ann Arbor stage III-IV or relapsed MALT after local treatment .
3. No prior systemic anti-lymphoma therapy (except for H. pylori eradication therapy in
H. pylori-positive gastric MALT patients).
4. No histopathological transformation to high-grade lymphoma.
5. At least one measurable lesion according to the Lugano 2014 criteria.
7. Age ≥ 18 years, with no gender restrictions. 7. An ECOG performance status score of
0-2. 8. An expected survival time of more than 12 months. 9. Adequate bone marrow,
cardiac, pulmonary, liver, and kidney function. 10. Willing to participate in the
clinical study; fully informed and aware of the study, having signed the informed
consent form; willing and able to comply with all study procedures.
Key exclusion Criteria:
1. Patients with a history of stroke, intracranial hemorrhage, or warfarin use within
the past 6 months.
2. Patients with central nervous system involvement.
3. Patients who have undergone allogeneic hematopoietic stem cell transplantation in
the past.
4. Patients who have previously used BTK inhibitors or received CD20 monoclonal
antibody therapy.
5, Patients with active infections, except for tumor-related B-symptom fever. 6. Patients
with a concurrent history of other malignancies, except for cured cervical carcinoma in
situ or basal cell carcinoma of the skin.
7. Patients receiving potent cytochrome P450 inhibitors. 8. Patients with severe
cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive
heart failure, or a history of myocardial infarction within the past 12 months.
9. Patients, as judged by the investigator, who have significant organ dysfunction or
uncontrollable comorbidities that pose a safety risk, or who have absorption and
metabolism issues with Zanubrutinib.
10. Pregnant or breastfeeding women and women of childbearing age unwilling to use
contraception.
11. Patients who have received anti-tumor therapy within 4 weeks prior to enrollment.
12. Patients with active chronic hepatitis B or active hepatitis C. 13. Patients who
have received systemic corticosteroid treatment or other immunosuppressive therapy
within 14 days prior to the start of study treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
51000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingqing Cai
Phone:
0086-20-87342823
Email:
caiqq@sysucc.org.cn
Start date:
October 25, 2024
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Gansu Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Beijing Tongren Hospital
Agency class:
Other
Collaborator:
Agency:
Tongji Medical College of Huazhong University of Science & Technology
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Shenzhen People's Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06647732
