Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma
Primary Purpose
T Cell Non-Hodgkin's Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chidamide
Cyclophosphamide
Epirubicin
Vindesine
Etoposide
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for T Cell Non-Hodgkin's Lymphoma focused on measuring Chidamide, T Cell Non-Hodgkin's Lymphoma
Eligibility Criteria
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
Sites / Locations
- Peking Union medical college hospitalRecruiting
- Tianjin medical universty cancer institute & hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C-CHOEP
Arm Description
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
5 years overall survival(OS)
from recruiting the first subject until the last recruited subject finished his 5 years follow-up phase
overall response rate(ORR) and complete remission rate(CR)
the last recruited subject finished 4 cycle C-CHOEP regimen
adverse events
throughout the treatment and until 30 days after the administration of the last dose of a study drug
Full Information
NCT ID
NCT02987244
First Posted
December 2, 2016
Last Updated
December 6, 2016
Sponsor
Peking Union Medical College Hospital
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
1. Study Identification
Unique Protocol Identification Number
NCT02987244
Brief Title
Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma
Official Title
Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Non-Hodgkin's Lymphoma
Keywords
Chidamide, T Cell Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C-CHOEP
Arm Type
Experimental
Arm Description
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
epidaza
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide(750mg/m2) was administered intravenously on d1
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
epirubicin (70mg/m2)was administered intravenously on d1;
Intervention Type
Drug
Intervention Name(s)
Vindesine
Intervention Description
vindesine (4mg)was administered intravenously on d1;
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
etoposide (100mg) was administered intravenously on d1,2,3.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
prednisone (60mg/m2)was administered intravenously by oral d1-5.
Primary Outcome Measure Information:
Title
2 years progression-free survival
Description
from recruiting the first subject until the last recruited subject finished his 2 years follow-up phase or the disease relapsed
Time Frame
the overall time frame is up to 48 months
Secondary Outcome Measure Information:
Title
5 years overall survival(OS)
Description
from recruiting the first subject until the last recruited subject finished his 5 years follow-up phase
Time Frame
the overall time frame is up to 84 months
Title
overall response rate(ORR) and complete remission rate(CR)
Description
the last recruited subject finished 4 cycle C-CHOEP regimen
Time Frame
the overall time frame is up to 30 months
Title
adverse events
Description
throughout the treatment and until 30 days after the administration of the last dose of a study drug
Time Frame
the overall time frame is up to 84 months
Other Pre-specified Outcome Measures:
Title
maximum tolerated dose of chidamide
Description
from recruiting the first 9 subjects to all of them received 1 cycle C-CHOEP regiment
Time Frame
the overall time frame is up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhang, M.D
Phone
+86 136 8147 3557
Email
vv1223@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhang, M.D
Phone
+86 13810000485
Email
zhangyan10659@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daobin Zhou, M.D
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union medical college hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang
Facility Name
Tianjin medical universty cancer institute & hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22362161
Citation
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.
Results Reference
background
PubMed Identifier
26105599
Citation
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.
Results Reference
background
PubMed Identifier
30209556
Citation
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.
Results Reference
derived
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Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma
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