Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma
A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma
1 other identifier
interventional
33
1 country
1
Brief Summary
This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedNovember 14, 2017
November 1, 2017
3 years
April 19, 2016
November 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
complete response
21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)
Secondary Outcomes (3)
Progression free survival
1 year
Overall survival
1 year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Each cycle of treatment and then every 3 months for 1 year（each cycle is 21 days）
Study Arms (1)
Chidamide plus previous chemotherapy
EXPERIMENTALChidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles
Interventions
Eligibility Criteria
You may qualify if:
- Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)
- Age ≧16 years, ≦75 years
- ECOG (Eastern Cooperative Oncology Group) =0,1,2
- No previous history of malignancy
- Radiologically measurable disease
- Life expectancy\>6 months
- Informed consented
You may not qualify if:
- Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
- Lab at enrollment(unless caused by lymphoma)
- Neutrophile\<1.5\*10\^9/L
- Platelet\<75\*10\^9/L
- Hemoglobulin\<90g/L
- ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) \>2\*ULN,AKP(alkaline phosphatase) or bilirubin \>1.5\*ULN (upper limit of normal )
- Creatinine\>1.5\*ULN
- Other uncontrollable medical condition that may that may interfere the participation of the study
- Not able to comply to the protocol for mental or other unknown reasons
- Pregnant or lactation
- HIV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital
Shanghai, Shanghai Municipality, 200023, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 19, 2016
First Posted
April 28, 2016
Study Start
November 1, 2015
Primary Completion
November 1, 2018
Study Completion
November 1, 2019
Last Updated
November 14, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share