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To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.
Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. The investigators have been proceeding this trial to evaluate the efficacy and safety of the PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly diagnosed PTCL | Experimental | PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle. |
|
| Relapse/refractory PTCL | Other | PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine | Drug | PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Gemcitabine is a cytosine nucleoside derivative, its main metabolite incorporates into DNA in cells and mainly acts on G1 / S phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation. | From date of randomization until the date tumor volume has reduced, assessed up to 36 months |
| Progression-free Survival | The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months |
| Overall Survival | Time from randomization to death for any reason | From date of randomization until date of death from any cause, assessed up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingzhi D Zhang | Contact | +8613838565629 | +8613838565629 | Mingzhi_zhang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department of The First Affilliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000077269 | Lenalidomide |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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50 patients for newly diagnosed group and 50 patients for relapse/refractory group.
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|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |