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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02753543

Enrollment

Registered

2016-04-28

Start date

2015-11-30

Completion date

2019-11-30

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral T Cell Lymphoma

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.

Interventions

DRUGChidamide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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）

Countries

China

Contacts

Primary ContactWeili Zhao, MD, PhD

zhao.weili@yahoo.com64370045

Backup ContactPengpeng Xu, MD

xpproc@msn.com64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026