Refractory or Relapsed Diffuse Large B Cell Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGZanubrutinib
160mg bid PO（d0-d20）
DRUGPolatuzumab Vedotin
Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 1.8mg/kg Polatuzumab Vedotin on Day 2 of each cycle.
DRUGBendamustine
Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 70 mg/m2 Bendamustine on Days 2 and 3 of each cycle.
DRUGRituximab
Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 375 mg/m2 Rituximab on Day 1 of each cycle.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 75 (inclusive); * For patients with DLBCL confirmed by histopathology (which needs to be confirmed by specimens after this or past recurrence), the following DLBCL histology will be considered eligible for study enrollment: DLBCL, NOS(includes GCB type and ABC type); T-cell rich large B-cell lymphoma; High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement; High-grade B-cell lymphoma, NOS; Primary mediastinal (thymus) large B-cell lymphoma; EB virus positive DLBCL, NOS;HHV-8 positive DLBCL, NOS; * Relapsed refractory patients, defined as those who had no response after first-line treatment (including immunochemotherapy, chemotherapy or hematopoietic stem cell transplantation) or relapsed or refractory after remission; * There is at least one two-dimensional measurable lesion with a short diameter ≥1.0cm; * Estimated survival time ≥3 months; * The patient is informed and agrees to the program; * ECOG score 0-2 points; * Those who understand the procedure and content of the experiment, voluntarily participate in the study and sign the informed consent; * Patients can follow up on schedule, communicate well with researchers and complete the trial according to the trial regulations; * Confirm negative pregnancy test of female patients of childbearing age within 7 days before administration; Women and men in the reproductive period must agree to use medically recognized effective contraception throughout the treatment period and for 6 months after the end of the trial.
Exclusion criteria
* Active bleeding within 4 weeks prior to initial administration or anticoagulant therapy such as warfarin or vitamin K antagonists during the study period, or a tendency to bleed (such as esophageal varicose veins at risk of bleeding, locally active ulcerative lesions) or a clotting disorder deemed by the investigator; * Surgical procedures have been performed within 6 weeks prior to the signing of the informed consent for the first dose of the trial drug, but tests for diagnostic purposes are not considered surgical procedures, and the insertion of a vascular access device will be exempt from this
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response rate（ORR） | Up to 12 weeks | The proportion of patients who achieved complete or partial response in efficacy evaluation at the end of induction treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response rate（CRR） | Up to 12 weeks | The proportion of patients who achieved complete response in efficacy evaluation at the end of induction treatment. |
| Progression-free Survival（PFS） | Up to 2 years after enrollment | PFS was defined as the period from date of enrollment until the date of disease progression, relapse, or death from any cause. |
| Overall Survival(OS) | Up to 2 years after enrollment | OS was defined as the time from date of randomization until the date of death from any cause. |
| Percentage of Participants With Adverse Events (AEs) | Up to 12 weeks | Toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 |
Countries
China
Contacts
Primary ContactXianggui Yuan
Backup ContactWenbin Qian
Outcome results
None listed