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For relapsed/refractory mantle cell lymphoma patients that previously treated with BTK inhibitors: The first part involves 6 cycles of combined therapy with zuberitamab, selinexor, dexamethasone, and thalidomide. This targeted combination regimen can enhance efficacy while reducing toxic side effects. The second part utilizes Zuberitamab plus selinexor for maintenance consolidation therapy, thereby reducing relapse and prolonging survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZSDT regemin | Experimental | This study enrolled 30 patients with relapsed refractory mantle cell lymphoma (MCL). The treatment protocol included: selinexor 60mg once daily on days 1 and 8, zuberitamab 375 mg/m² on day 0, Dexamethasone 20 mg on days 1-3 and 8-9, and thalidomide 200 mg on days 1-21. Each treatment cycle lasted 21 days, with six consecutive cycles. Patients achieving complete remission (CR) or partial response (PR) would receive a year-long maintenance therapy of zuberitamab 375 mg/m² every three months and selinexor 60 mg daily on days 1 and 8. Patients experiencing disease progression (PD) would be excluded from the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZSDT regimen | Drug | The study is based on the R2 protocol and preclinical and clinical studies of selinexor. For relapsed refractory MCL patients who had received BTK inhibitors: selinexor 60mg once daily on days 1 and 8, zuberitamab 375 mg/m² on day 0, Dexamethasone 20 mg on days 1-3 and 8-9, and thalidomide 200 mg on days 1-21. Each treatment cycle lasted 21 days, with six consecutive cycles. Patients achieving complete remission (CR) or partial response (PR) would receive a year-long maintenance therapy of zuberitamab 375 mg/m² every three months and selinexor 60 mg daily on days 1 and 8. Patients experiencing disease progression (PD) would be excluded from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| CRR | comple remission rate | From enrollment to the end of treatment at 8 weeks |
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Inclusion Criteria:
5.Acceptable hematologic parameters, no contraindications to chemotherapy, absolute neutrophil ≥1.0 × 10 ^ 9 L, platelet ≥75 × 10 ^ 9 L, hemoglobin ≥80 g/L (except for patients with bone marrow infiltration) 6.Liver function: direct bilirubin ≤1.5 × upper limit , Alanine transaminase or aspartate transaminase ≤2.5 × upper limit , Alkaline phosphatase≤3 × ULN in patients without non-bone involvement 7.Renal function: serum creatinine ≤1.5 ×ULN 5; 8.Women of Childbearing Potential (WOBCP) or men and their WOBCP partners should agree to take effective contraceptive measures from the signing of ICF and WOBCP must undergo a serum pregnancy test within seven days before the first medication and the results are negative; 9.Recurrent refractory patients after BTK inhibitor treatment; 10.The subjects voluntarily participate the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang | Contact | 13938247096 | liyananread@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Professor Zhang | The first affliated hospital of ZhengZhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhengzhou University | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |