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| Name | Class |
|---|---|
| Fudan University | OTHER |
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This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of selinexor in combination with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) followed by selinexor maintenance for untreated TP53-mutated diffuse large B-cell lymphoma (DLBCL) patients.
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of selinexor in combination with R-CHOP for untreated TP53-mutated DLBCL patients.
The induction phase consisted of 8 cycles of selinexor in combination with R-CHOP. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with selinexor will be conducted.
The primary endpoint is complete response rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selinexor in combination with R-CHOP | Experimental | Patients with TP53-mutated diffuse large B-cell lymphoma will receive selinexor in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle). After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with selinexor will be conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor Oral Tablet [Xpovio] | Drug | Selinexor (60mg po D1, 8) is added from the second cycle of R-CHOP regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | To investigate the preliminary anti-tumor efficacy | Up to 8 cycles (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | To investigate the preliminary anti-tumor efficacy | From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Objective response rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| The gene mutations such as DDX3X、TET2、PTPN2 and so on are sequenced by whole genome sequencing | To explore the correlations between gene mutations and response and prognosis | Through study completion, an average of 2 years |
| The RNA alterations are sequenced by transcriptome sequencing |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| QingQing Cai, MD. PhD. | Contact | 0086-20-87342823 | caiqq@sysucc.org.cn | |
| Yi Xia, MD. PhD. | Contact | 0086-20-87342823 | xiayi@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| QingQing Cai, MD. PhD. | Sun yat-sen university cancer cente | Principal Investigator |
| Yi Xia, MD. PhD. | Sun yat-sen university cancer cente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen university cancer center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| 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 |
| D000097606 | Exportin 1 Protein |
| C571759 | R-CHOP protocol |
| ID | Term |
|---|---|
| D028884 | Karyopherins |
| D029543 | Nucleocytoplasmic Transport Proteins |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
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| R-CHOP Protocol | Drug | Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone |
|
|
To investigate the preliminary anti-tumor efficacy |
| Up to 8 cycles (each cycle is 21 days) |
| Progression-free survival (PFS) | To investigate the preliminary anti-tumor efficacy | From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Overall survival (OS) | To investigate the preliminary anti-tumor efficacy | From the date of enrollment until the date of death from ant cause, assessed up to 24 months |
| Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0 | To identify the incidence of AE and SAE | Through study completion, an average of 2 years |
| Duration of response (DOR) | To investigate the preliminary anti-tumor efficacy | From date of the first CR or PR to the first documented progressive disease or death, whichever occurred earlier, assessed up to 24 months |
| Time to response (TTR) | To investigate the preliminary anti-tumor efficacy | From the date of enrollment until the first response, assessed up to 24 weeks |
To explore the correlations between RNA alterations and response and prognosis |
| Through study completion, an average of 2 years |
| Genetic classification of DLBCL | To explore the correlations between genetic classification of DLBCL and response and prognosis | Through study completion, an average of 2 years |
| Rong Tao, MD. |
| Fudan University |
| Principal Investigator |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D009687 | Nuclear Proteins |
| D018160 | Receptors, Cytoplasmic and Nuclear |