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| Name | Class |
|---|---|
| Zhejiang Provincial People's Hospital | OTHER |
| The First Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
| Zhejiang Provincial Tongde Hospital | OTHER |
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Assess the efficacy and safety of glofitamab in combination with selinexor for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in patients who have received at least two prior lines of systemic therapy.
Currently, patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have failed at least two lines of systemic therapy have a poor prognosis, and there is a significant clinical need for new treatment options. Glofitamab and selinexor have both demonstrated clinical activity as single agents in R/R DLBCL. Because their mechanisms of action are complementary and their toxicity profiles do not overlap significantly, this combination holds the potential to further improve outcomes. Therefore, this study plans to assess the efficacy and safety of glofitamab in combination with selinexor for the treatment of R/R DLBCL patients who have previously received at least two lines of systemic therapy. Enrolled patients will receive study treatments for up to 12 cycles, with each 21-day period being one cycle. Cycle 1 involves obinutuzumab pre-treatment and step-up dosing of glofitamab. From Cycle 2 to Cycle 12, patients will receive glofitamab in combination with oral selinexor. Interim efficacy evaluations will be conducted during the treatment. At the end of the 12 cycles or upon treatment discontinuation, a final efficacy evaluation will be conducted, followed by a long-term follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glofitamab + Selinexor Cohort | Patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) receiving up to 12 cycles of glofitamab in combination with selinexor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glofitamab combined with selinexor | Drug | Patients receive obinutuzumab 1000 mg intravenously (IV) on Day 1 of Cycle 1 to mitigate cytokine release syndrome (CRS) risk. Glofitamab is administered IV with step-up dosing at 2.5 mg on Day 8 and 10 mg on Day 15 of Cycle 1, followed by a target dose of 30 mg on Day 1 of Cycles 2 through 12. Selinexor is administered orally at 60 mg on Days 1 and 3 of each week, starting from Cycle 2 through Cycle 12. Each cycle is 21 days. The total fixed duration of treatment is 12 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR) | Proportion of patients achieving a best overall response of complete response (CR) as assessed by the investigator according to the 2014 Lugano Classification criteria based on PET/CT or CT scans. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of patients achieving a best overall response of partial response (PR) or complete response (CR) as assessed by the investigator according to the 2014 Lugano Classification criteria. | Up to approximately 2 years |
| Duration of Complete Response (DoCR) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have previously received at least two lines of systemic therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiefeng Tong | Contact | 13588710821 | jeffytong@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C585161 | selinexor |
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| Affiliated Hospital of Jiaxing University |
| OTHER |
| Shaoxing People's Hospital | OTHER |
| Shaoxing Central Hospital | OTHER |
| Zhuji People's Hospital of Zhejiang Province | OTHER |
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Time from the first documented complete response (CR) to the first documented disease progression or death from any cause, whichever occurs first. |
| Up to approximately 2 years |
| Progression-Free Survival (PFS) | Time from the start of study treatment to the first documented disease progression or death from any cause, whichever occurs first. | Up to approximately 2 years |
| Overall Survival (OS) | Time from the start of study treatment to death from any cause. | Up to approximately 2 years |
| Incidence and Severity of Adverse Events (AEs) | Incidence and severity of AEs graded according to NCI CTCAE v5.0, with Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) graded according to the ASTCT 2019 consensus criteria. | From baseline up to 90 days after the last dose of study treatment (assessed up to approximately 2 years) |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |