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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a prospective, single arm, single center study to evaluate the efficacy and safety of Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell lymphoma.
This is a prospective, single arm, single center study, including two phases. It plans to recruit36 patients with clinically diagnosed primary PTCL who will be treated with Duvelisib and Chidamide. In the first phase Duvelisib is Oral administration at a dose of 25mg twice a day, and every 4 weeks (28 days) was a cycle. Next administration will be depend on whether the efficacy reaches CR in the second phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duvelisib-Chidamide | Experimental | Patients with newly diagnosed PTCL were treated with a combination of Duvelisib and Chidamide. The dose of Duvelisib was 25mg twice a day. Every 4 weeks (28 days) is a cycle with a total of 2 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duvelisib, Chidamide | Drug | Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0) | To identify the incidence of AE and SAE in clinical trial | from the initiation of the first dose to 28 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | To evaluate the efficacy of anti-lymphoma | up to 26 weeks |
| Complete remission rate (CR) | To evaluate the efficacy of anti-lymphoma |
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Inclusion Criteria:
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1.Age: 18-70 Years (Contains boundary values 18 and 70);
2.The newly diagnosed PTCL confirmed by histopathology is one of the following subtypes;
a) Angioimmunoblastic T-cell lymphoma (AITL); b) Follicular T helper cell lymphoma (T-FHCL); Including but not limited to the above two subtypes;
3.ECOG ≤ 3;
4.At least one measurable or evaluable tumor lesion according to the Lugano-2014 standard;
5.Expected survival ≥ 3 months;
6.Subjects fully understand and voluntarily participate in this study and sign informed consent;
Exclusion Criteria:
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1.Subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liling Zhang, M.D | Contact | 0086 27 83262660 | lily1228@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Liling Zhang, M.D | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
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| up to 26 weeks |
| Duration of Response(DOR) | To evaluate the efficacy of anti-lymphoma | The time from the first assessment as CR or PR to the first assessment as PD or death (due to any cause),assessed up to 12 months |
| Progression free survival (PFS) | To evaluate the efficacy of anti-lymphoma | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months |
| Overall survival (OS) | To evaluate the efficacy of anti-lymphoma | From date of randomization until the date of death from any cause, assessed up to 20 months |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C586691 | duvelisib |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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