Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma
NCT ID: NCT02987244
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2016-03-31
2023-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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C-CHOEP
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
Chidamide
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.
Cyclophosphamide
Cyclophosphamide(750mg/m2) was administered intravenously on d1
Epirubicin
epirubicin (70mg/m2)was administered intravenously on d1;
Vindesine
vindesine (4mg)was administered intravenously on d1;
Etoposide
etoposide (100mg) was administered intravenously on d1,2,3.
Prednisone
prednisone (60mg/m2)was administered intravenously by oral d1-5.
Interventions
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Chidamide
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.
Cyclophosphamide
Cyclophosphamide(750mg/m2) was administered intravenously on d1
Epirubicin
epirubicin (70mg/m2)was administered intravenously on d1;
Vindesine
vindesine (4mg)was administered intravenously on d1;
Etoposide
etoposide (100mg) was administered intravenously on d1,2,3.
Prednisone
prednisone (60mg/m2)was administered intravenously by oral d1-5.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG≤2
* At least one or more unidimensionally measurable lesions (≥1 cm by CT scan or skin lesions or a measurable lesion by physical examination)
* Sign the Informed consent
* Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.
* Male subjects must agree to use condoms throughout study drug therapy.
Exclusion Criteria
* Bone marrow involvement and lymphoma cell ≥ 25%
* Aplastic large T cell lymphoma - ALK positive
* NK/T-cell lymphoma
* Mycosis Fungoides/Sezary Syndrome
* Pre-existing uncontrolled active infection
* Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria
* Grade 3 or 4 peripheral neuropathy
* Pregnancy or active lactation
* Co-existing tumors
* Impaired renal/ hepatic function (serum creatinine \>1.5 mg/dl or creatinine clearance \<60 ml/min or serum transaminases/ bilirubin ≥3 upper limits of normal）
* History of mental illness
18 Years
70 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Peking University First Hospital
OTHER
Peking University Third Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Daobin Zhou, M.D
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union medical college hospital
Beijing, Beijing Municipality, China
Tianjin medical universty cancer institute & hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wei Zhang
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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PUMCH-NHL-002
Identifier Type: -
Identifier Source: org_study_id