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

Sponsor
Ruijin Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02753543
Collaborator
(none)
33
Enrollment
1
Location
1
Arm
48
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Nov 1, 2015
Anticipated Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chidamide plus previous chemotherapy

Chidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles

Drug: Chidamide

Outcome Measures

Primary Outcome Measures

  1. complete response [21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)]

Secondary Outcome Measures

  1. Progression free survival [1 year]

  2. Overall survival [1 year]

  3. 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）]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 )

2ULN,AKP(alkaline phosphatase) or bilirubin >1.5ULN (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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital Shanghai Shanghai China 200023

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhao Weili, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT02753543
Other Study ID Numbers:
  • RJ-PTCL-2016-01
First Posted:
Apr 28, 2016
Last Update Posted:
Nov 14, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Nov 14, 2017