Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma

Peripheral T Cell Lymphoma Clinical Trial

Official title:

A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02753543
• Other study ID #: RJ-PTCL-2016-01
• Status: Recruiting
• Phase: Phase 2
• First received: April 19, 2016
• Last updated: November 10, 2017
• Start date: November 2015
• Est. completion date: November 2019

Study information

• Verified date: November 2017
• Source: Ruijin Hospital
• Contact: Weili Zhao, MD, PhD
• Phone: 64370045
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

Intervention

Drug:
• Chidamide

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response		21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)
Secondary	Progression free survival		1 year
Secondary	Overall survival		1 year
Secondary	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)