Clinical trial · Interventional

Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma

NCT02987244CI-TRIAL-00025074unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
T Cell Non-Hodgkin's Lymphoma	T-Cell Non-Hodgkin Lymphoma	ALIAS	0.90

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
Chidamide	Drug	—	UNRESOLVED
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Epirubicin	Drug	Epirubicin	ALIAS
Etoposide	Drug	Etoposide	ALIAS
Prednisone	Drug	Prednisone	ALIAS
Vindesine	Drug	Vindesine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
C-CHOEP
description
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
interventionNames
1. Drug: Chidamide
2. Drug: Cyclophosphamide
3. Drug: Epirubicin
4. Drug: Vindesine
5. Drug: Etoposide
6. Drug: Prednisone

Primary outcomes (1)

measure
2 years progression-free survival
timeFrame
the overall time frame is up to 48 months
description
from recruiting the first subject until the last recruited subject finished his 2 years follow-up phase or the disease relapsed

Secondary outcomes (3)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

* Newly-diagnosed T cell non-Hodgkin's lymphoma patients. Diagnosis of T cell NHL was performed by morphologic analysis of tissue pathological specimens along with Immunohistochemistry (IHC)
* 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:

* T lymphoblastic leukemia/lymphoma
* 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

References

Publications (4)

BACKGROUNDDong 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. PMID 22362161
BACKGROUNDShi 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. PMID 26105599
DERIVEDWang 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. PMID 38805037
DERIVEDZhang 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. PMID 30209556

Registry

Dates and enrollment

Start: Mar 1, 2016
Primary completion: Mar 1, 2020
Completion: Mar 1, 2023
First posted: Dec 8, 2016
Last update posted: Dec 8, 2016
Enrollment: 100 (estimated)
Lead sponsor: Peking Union Medical College Hospital OTHER
Collaborators: Chinese PLA General Hospital; Peking University First Hospital; Peking University Third Hospital; Peking University Cancer Hospital & Institute; Tianjin Medical University Cancer Institute and Hospital
Keywords: Chidamide, T Cell Non-Hodgkin's Lymphoma

Data updated 22 days agoSource updated Dec 8, 2016source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
China	2	2

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.