Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| Peking University First Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Peking University Cancer Hospital & Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine determine the maximum tolerated dose (MTD) and safety of the combination of Chidamide combined with CHOEP(cyclophosphamide, epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in newly-diagnosed T-NHL.
Chidamide+Cyclophosphamide+Epirubicin+Vindesine+Etoposide+Prednisone Six cycles of therapy administered every 28 days were planned. Cyclophosphamide 750mg/m2 IV d1; epirubicin 70mg/m2 IV d1; Vindesine 4mg IV d1; etoposide 100mg IV d1-3; prednisone 60mg/m2 PO d1-5.
Chidamide:
Phase I: Patients were treated at the following bortezomib dose levels: 15, 20, and 25 mg twice per week.
Dose escalation and reduction were on the basis of the continual reassessment method, with at least two patients per dose level and no dose level skipped. No intrapatient dose escalation will be allowed. If one patient experienced dose-limiting toxicity (DLT), three additional patients were added to the dose level. If two of six patients experienced DLT, the previous dose level was declared the MTD. If only one of six patients experienced DLT, dose escalation was permitted to continue. DLT refers only to toxic events that occur during the first cycle of treatment.
At least 9(3+3+3) patients will be enrolled in Phase I study. Phase II: If MTD was not reached at 25mg dose level of Chidamide. The followed study will use 20mg twice per week as experimental dose.
After 3 Cycles, patients who become PD should withdraw the trial and receive other regimens; patients who become CR and eligible for auto-SCT will undergo auto-SCT; patients who get PR will receive 3 more cycles C-CHOEP regimen treatment, CR patients in them undergo auto-SCT, non-CR patients undergo follow-up phase.
All the patients will continue to receive chidamide treatment until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
During follow-uo phase, surveillance imaging with CT scans can be performed every 6 months up to the first 2 years, followed by doctor visit every 6 months up to 5 years or the disease relapses.
from recruiting the first subject until the last recruited subject finished his 2 years follow-up phase or the disease relapsed
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-CHOEP | Experimental | experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | Six cycles of therapy will be administered,and each cycle of treatment is 28 days. Phase I: Patients were treated at the following dose levels: 15, 20, and 25 mg twice per week to determine the MDT Phase II: If MTD was not reached at 25mg dose level of Chidamide. The followed study will use 20mg twice per week as experimental dose. |
| Measure | Description | Time Frame |
|---|---|---|
| 2 years progression-free survival | from recruiting the first subject until the last recruited subject finished his 2 years follow-up phase or the disease relapsed | the overall time frame is up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 5 years overall survival(OS) | from recruiting the first subject until the last recruited subject finished his 5 years follow-up phase | the overall time frame is up to 84 months |
| overall response rate(ORR) and complete remission rate(CR) |
| Measure | Description | Time Frame |
|---|---|---|
| maximum tolerated dose of chidamide | from recruiting the first 9 subjects to all of them received 1 cycle C-CHOEP regiment | the overall time frame is up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhang, M.D | Contact | +86 136 8147 3557 | vv1223@vip.sina.com | |
| Yan Zhang, M.D | Contact | +86 13810000485 | zhangyan10659@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Daobin Zhou, M.D | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union medical college hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22362161 | Background | Dong M, Ning ZQ, Xing PY, Xu JL, Cao HX, Dou GF, Meng ZY, Shi YK, Lu XP, Feng FY. Phase I study of chidamide (CS055/HBI-8000), a new histone deacetylase inhibitor, in patients with advanced solid tumors and lymphomas. Cancer Chemother Pharmacol. 2012 Jun;69(6):1413-22. doi: 10.1007/s00280-012-1847-5. Epub 2012 Feb 24. | |
| 26105599 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D003520 | Cyclophosphamide |
| D015251 | Epirubicin |
| D014751 | Vindesine |
| D005047 | Etoposide |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
| OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Cyclophosphamide | Drug | Cyclophosphamide(750mg/m2) was administered intravenously on d1 |
|
| Epirubicin | Drug | epirubicin (70mg/m2)was administered intravenously on d1; |
|
| Vindesine | Drug | vindesine (4mg)was administered intravenously on d1; |
|
| Etoposide | Drug | etoposide (100mg) was administered intravenously on d1,2,3. |
|
| Prednisone | Drug | prednisone (60mg/m2)was administered intravenously by oral d1-5. |
|
the last recruited subject finished 4 cycle C-CHOEP regimen
| the overall time frame is up to 30 months |
| adverse events | throughout the treatment and until 30 days after the administration of the last dose of a study drug | the overall time frame is up to 84 months |
| Tianjin medical universty cancer institute & hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. doi: 10.1093/annonc/mdv237. Epub 2015 Jun 23. |
| 38805037 | Derived | Wang W, Zhang W, Su LP, Liu LH, Gao YH, Wang QS, Su H, Song YQ, Zhang HL, Shen J, Jing HM, Wang SY, Cen XN, Liu H, Liu AC, Li ZJ, Luo JM, He JX, Wang JW, O'Connor OA, Zhou DB. Efficacy of chidamide maintenance therapy versus autologous stem cell transplantation versus observation as a post-remission choice in the survival of adult patients with peripheral T-cell lymphoma: Post hoc analysis of a prospective, multicenter, phase 2 study in China. Ann Hematol. 2024 Aug;103(8):3061-3069. doi: 10.1007/s00277-024-05708-w. Epub 2024 May 28. |
| 30209556 | Derived | Zhang Y, Zhang W, Li J, Duan M, Han B, Zhu T, Zhuang J, Cai H, Cao X, Chen M, Zhou D. Gemcitabine, cisplatin, and dexamethasone (GDP) in combination with methotrexate and pegaspargase is active in newly diagnosed peripheral T cell lymphoma patients: a phase 2, single-center, open-label study in China. Ann Hematol. 2019 Jan;98(1):143-150. doi: 10.1007/s00277-018-3488-1. Epub 2018 Sep 12. |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |