Actively Recruiting
ZR2 Sequential Immunochemotherapy for Newly Treated MCL
Led by Zhejiang Cancer Hospital · Updated on 2023-09-21
48
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with newly diagnosed MCL were treated with ZR2 regimen for 3 cycles, followed by 3 cycles of immunochemotherapy, and zebrutinib maintenance therapy for 2 years after the end of induction therapy, in order to improve the remission rate and prognosis of patients with induction therapy.
CONDITIONS
Official Title
ZR2 Sequential Immunochemotherapy for Newly Treated MCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years, male or female
- Histopathologically confirmed mantle cell lymphoma with positive CyclinD1 or chromosomal t (11;14)
- No prior anti-tumor therapy including chemotherapy, radiotherapy, immunotherapy, or biotherapy
- At least one evaluable or measurable lesion meeting Lugano2014 criteria
- Adequate organ and bone marrow function without serious hematopoietic dysfunction or major organ abnormalities
- Left ventricular ejection fraction (LVEF) of at least 50%
- Male participants agree to effective contraception during and for 6 months after treatment
- Life expectancy greater than 3 months
- Willingness to participate voluntarily and ability to complete all study procedures
You will not qualify if you...
- Diagnosis of leukemic mantle cell lymphoma
- Central nervous system involvement secondary to lymphoma
- History of other active malignant diseases within 2 years except certain treated cancers
- Known history of HIV infection or AIDS
- Active hepatitis B or C infection requiring treatment
- Major surgery within 28 days before study start
- Active infections requiring systemic treatment within 14 days before treatment
- Severe or uncontrolled diseases such as congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer, or history of severe bleeding disorders
- History of stroke or intracranial hemorrhage within 6 months before treatment
- History of deep vein thrombosis or pulmonary embolism within past 12 months
- Need for concurrent antiplatelet and anticoagulant therapy without alternatives
- Recent use of strong or moderate CYP3A inhibitors or inducers within 7 days before treatment
- Other conditions deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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