Actively Recruiting
A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-08-15
36
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, single-arm, open phase II study to explore the efficacy and safety of Zanubrutinib in combination with Polatuzumab Vedotin, bendamustine, and rituximab (Polo-ZBR) in subjects with relapsed/refractory diffuse large B-cell lymphoma. Subjects with relapsed/refractory DLBCL who met the inclusion/exclusion criteria were screened and treated with 4 courses of Pola-ZBR regimen after signing informed consent. Subjects achieving PR or CR were consolidated with autologous transplantation consolidation or the original regimen for 2 additional courses, and then given Zanubrutinib maintenance therapy for 1 year. The final follow-up was observed until 2 years after enrollment.
CONDITIONS
Official Title
A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 (inclusive)
- Diagnosed with diffuse large B-cell lymphoma confirmed by histopathology, including specific subtypes
- Relapsed or refractory after first-line treatment or stem cell transplantation
- At least one measurable lesion with a short diameter of 1.0 cm or more
- Estimated survival time of at least 3 months
- Informed and agrees to participate in the study
- ECOG performance status of 0 to 2
- Understands the study procedures and voluntarily signs informed consent
- Able to follow up on schedule, communicate with researchers, and complete the trial
- Female patients of childbearing age must have a negative pregnancy test within 7 days before starting treatment
- Women and men of reproductive potential must agree to use effective contraception during treatment and for 6 months after the study
You will not qualify if you...
- Active bleeding within 4 weeks before starting treatment or use of certain anticoagulants during the study
- Surgery within 6 weeks before signing informed consent, except diagnostic tests or vascular access device insertion
- History of stroke or intracranial hemorrhage within 6 months before first treatment dose
- Unable to stop or adjust moderate or strong CYP3A inhibitors
- Previous organ or allogeneic stem cell transplantation
- Previous or current other malignant tumors
- Active infections requiring systemic treatment, except EBV infections
- Uncontrolled cardiovascular, cerebrovascular, thrombotic, connective tissue, or other serious diseases
- Abnormal laboratory values at screening unless due to lymphoma
- Positive hepatitis B or C virus tests without controlled viral load
- Positive HIV or syphilis tests
- Pregnant or lactating women
- History of drug abuse
- Poor communication, understanding, or compliance
- Known allergy to study drugs or ingredients
- Past or current lymphoma involvement of the central nervous system
- Inability to swallow capsules or severe gastrointestinal conditions
- Use of other antitumor drugs within 2 weeks before study treatment
- Other reasons deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
X
Xianggui Yuan
CONTACT
W
Wenbin Qian
CONTACT
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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