Chidamide for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chidamide,a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). Moreover, the aim was to study the correlation of clinical efficacy to mutation of certain genes as well.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
  2. 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;
  3. pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
  4. Patients have undergone organ transplantation;
  5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
  6. Patients with active hemorrhage.
  7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
  8. Patients with active infection, or with continuous fever within 14 days prior to enrollment.
  9. Had major organ surgery within 6 weeks prior to enrollment.
  10. 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).
  11. Patients with mental disorders or those do not have the ability to consent.
  12. Patients with drug abuse, long term alcoholism that may impact the results of the trial.
  13. Patients who have central nervous system involvements;
  14. Non-appropriate patients for the trial according to the judgment of the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Drug: Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
Other Names:
  • Chidamide single agnet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate(ORR)
Time Frame: up to 2 years
the total proportion of patients with complete response(CR or CRu)and partial response(PR)
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: up to 2 years
the total proportion of patients with complete response(CR or CRu), partial response(PR)and Stable Disease(SD)
up to 2 years
progression-free survival(PFS)
Time Frame: 2 years
Time from treatment until disease progression or death
2 years
overall survival(OS)
Time Frame: 2 years
Time from treatment until death from any cause
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 25, 2018

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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