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

Phase 2

• Conditions: Peripheral T Cell Lymphoma
• Interventions: Drug: Chidamide

• Registration Number: NCT02753543
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14
• Primary Completion: 2018-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chidamide plus previous chemotherapy	Chidamide	Chidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles

Primary Outcome Measures

Name	Time	Method
complete response	21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)

Secondary Outcome Measures

Name	Time	Method
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）

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China