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

NCT02987244 | Unknown Phase 1

• 1 other identifier: PUMCH-NHL-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

T Cell Non-Hodgkin's Lymphoma

Keywords

Chidamide, T Cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 5 years overall survival（OS）

  the overall time frame is up to 84 months

• overall response rate(ORR) and complete remission rate(CR）

  the overall time frame is up to 30 months

• adverse events

  the overall time frame is up to 84 months

Other Outcomes (1)

• maximum tolerated dose of chidamide

  the overall time frame is up to 6 months

Study Arms (1)

C-CHOEP

EXPERIMENTAL

experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.

Drug: Chidamide; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vindesine; Drug: Etoposide; Drug: Prednisone

Interventions

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.

Also known as: epidaza

C-CHOEP

Cyclophosphamide DRUG

Cyclophosphamide(750mg/m2) was administered intravenously on d1

C-CHOEP

Epirubicin DRUG

epirubicin (70mg/m2)was administered intravenously on d1;

C-CHOEP

Vindesine DRUG

vindesine (4mg)was administered intravenously on d1;

C-CHOEP

Etoposide DRUG

etoposide (100mg) was administered intravenously on d1,2,3.

C-CHOEP

Prednisone DRUG

prednisone (60mg/m2)was administered intravenously by oral d1-5.

C-CHOEP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Chinese PLA General Hospital: collaborator
• Peking University First Hospital: collaborator
• Peking University Third Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (2)

Peking Union medical college hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Tianjin medical universty cancer institute & hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 22362161 BACKGROUND

• 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.

  PMID: 26105599 BACKGROUND

• 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.

  PMID: 38805037 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.

  PMID: 30209556 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Cyclophosphamide; Epirubicin; Vindesine; Etoposide; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Daobin Zhou, M.D

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhang, M.D

CONTACT

+86 136 8147 3557; vv1223@vip.sina.com

Yan Zhang, M.D

CONTACT

+86 13810000485; zhangyan10659@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 8, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2023
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)