NCT03268889

Brief Summary

This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

August 30, 2017

Last Update Submit

August 30, 2017

Conditions

Peripheral T Cell Lymphoma

Keywords

Chidamide, CHOP regimen

Outcome Measures

Primary Outcomes (1)

  • Complete Remission Rate

    the rate of patients who achieve complete remission after the treatment

    every 3 months until 30 months after the last patient's enrollment

Secondary Outcomes (4)

  • progression free survival

    from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment

  • duration of remission

    from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment

  • overall survival

    30 months after the last patient's enrollment

  • adverse events

    from the date of first cycle of treatment to 30 months after last patient's enrollment

Study Arms (1)

treatment group

EXPERIMENTAL

In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.

Drug: Chidamide

Interventions

ChidamideDRUG

Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.

Also known as: CHOP regimen
treatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria（NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded）;
  • De novo peripheral T cell lymphoma patients;
  • Age 18-70 years old;
  • ECOG≤2；
  • Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter;
  • The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci);
  • Willing to sign a written consent.

You may not qualify if:

  • T lymphoblast lymphoma;
  • Bone marrow infiltrated with lymphoma cell ≥25%；
  • NT/T cell lymphoma;
  • Granuloma fungoides;
  • Severe impaired liver/ renal function (ALT, Bilirubin or creatinine \>3 times the normal maximum);
  • Uncontrolled infection;
  • Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2);
  • With other tumors;
  • With other condition that cause the patient unable to sign the written consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Related Publications (1)

  • Zong X, Yang Z, Zhou J, Jin Z, Wu D. Clinical trial: Chidamide plus CHOP improve the survival of newly diagnosed angioimmunoblastic T-cell lymphoma. Front Immunol. 2024 Aug 20;15:1430648. doi: 10.3389/fimmu.2024.1430648. eCollection 2024.

    PMID: 39229263DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamideVAP-cyclo protocol

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Zhengming Jin, MD,PhD

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengming Jin, MD,PhD

CONTACT

（+86）512-65223637suzhouhematology@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

August 31, 2017

Study Start

June 15, 2017

Primary Completion

June 15, 2020

Study Completion

September 15, 2020

Last Updated

August 31, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

All the data would be available at the First Affiliated Hospital after the study is finished

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
From the time of study finish

Locations

CN(1)