NCT03410004

Brief Summary

Study of Chidamide as a single-agent treatment for patients with relapse or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2018

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

First Submitted

Initial submission to the registry

January 12, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

January 12, 2018

Last Update Submit

January 23, 2018

Conditions

Experimental

Outcome Measures

Primary Outcomes (1)

  • objective response rate（ORR）

    the total proportion of patients with complete response（CR or CRu）and partial response（PR）

    up to 2 years

Secondary Outcomes (3)

  • Disease Control Rate （DCR）

    up to 2 years

  • progression-free survival（PFS）

    2 years

  • overall survival（OS）

    2 years

Study Arms (1)

Experimental

EXPERIMENTAL

Drug: Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.

Drug: Chidamide

Interventions

ChidamideDRUG

Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.

Also known as: Chidamide single agnet
Experimental

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) according to "2016 WHO classification of tumors of haematopoietic and lymphoid tissues";
  • Patients must have received systemic treatment (including chemotherapy or Hematopoietic stem cell transplantation), but did not achieve remission or had relapse after remission;
  • At least one measurable lesion;
  • Age 18-75 years, male or female;
  • ECOG performance status 0-1;
  • Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;.
  • Life expectancy no less than 3 months;
  • Not received chemotherapy, targeted medicine or stem cell transplantation 3 weeks before enrollment;
  • Patients have signed the Informed Consent Form.

You may not qualify if:

  • Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
  • QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
  • pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
  • Patients have undergone organ transplantation;
  • Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
  • Patients with active hemorrhage.
  • Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
  • Patients with active infection, or with continuous fever within 14 days prior to enrollment.
  • Had major organ surgery within 6 weeks prior to enrollment.
  • Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
  • Patients with mental disorders or those do not have the ability to consent.
  • Patients with drug abuse, long term alcoholism that may impact the results of the trial.
  • Patients who have central nervous system involvements;
  • Non-appropriate patients for the trial according to the judgment of the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Study Officials

  • Yuankai Shi, Dr.

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuankai Shi, Dr.

CONTACT

010-67781331syuankai@cicams.ac.cn

Shengyu Zhou, Dr.

CONTACT

010-67781331typhoonwho@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 25, 2018

Study Start

January 25, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2020

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share