Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma

March 31, 2020 updated by: Yanyan Liu, Henan Cancer Hospital

The Efficacy and Safety of Chidamide Combined With VDDT Regimen（Vinorelbine，Liposomal Doxorubicin，Dexamethasone and Thalidomide） in Relapse and Refractory Patients With Diffuse Large B Cell Lymphoma

This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with VDDT(vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide) in relapsed and refractory patients with diffuse large B-cell lymphoma(DLBCL).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are one third of diffuse large B-cell Lymphoma patients suffering relapse and refractory, which are the major cause of death among these patients. Vinorelbine，liposomal doxorubicin，mitoxantrone, dexamethasone and thalidomide have been used in the therapy of patients who failed with Second-line treatments in our center. This regimen is well tolerated but the effect needs to be improved. Chidamide，a histone deacetylase inhibitor has been approved for the treatment of refractory T-cell lymphoma in China. The goal is to assess the efficacy and safety of chidamide combined with VDDT（vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide） in relapse and refractory patients with diffuse large B-cell Lymphoma.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Locations

  • China
    • Henan
      • ZhengZhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yanyan Liu, M.D.

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 based on the 2008 WHO classification of tumors of haematopoietic and lymphoid tissues
  2. Failed with second-line therapy
  3. Having at least one measurable lesions
  4. Age between 18 to 75 years old
  5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
  6. Neutrophils more than 1.5*10^9/L; Platelets more than 90*10^9/L Hemoglobin: more than 90g/L.
  7. Life expectancy no less than 3 months
  8. No receiving chemotherapy in 4 weeks before enrollment
  9. Agreeing to sign the written informed consents

Exclusion Criteria:

  1. Pregnant ，lactating and patients at reproductive age who refuse to practice contraception
  2. QTc prolonging >450ms，ventricular tachycardia，atrial fibrillation，cardiac conduction block， myocardial infarction in less than 1 year， congestive heart failure，coronary heart disease which needs medication.
  3. Organ transplant recipients
  4. Active bleeding
  5. Thrombus，embolism，cerebral hemorrhage，cerebral infarction
  6. Important organ operation in less than 6 weeks
  7. Abnormal liver function（Note：total bilirubin >1.5 times the upper limit of normal，AST or ALT >2.5 times the upper limit of normal （Note：5 times the upper limit of normal for patients with liver involvement）），abnormal renal function（Note：serum creatinine >1.5 times the upper limit of normal），fluid and electrolyte disorders
  8. Mental illness or unable to sign the informed consent
  9. Drug addiction history or alcoholism which may interfere the experimental results.
  10. Researchers determine unsuited to participate in this trial
  11. Known allergy to any kind of study drugs

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: Chidamide combined with VDDT regimen
Chidamide 30mg，Oral twice a week with an interval of no less than 3 days combined with regimen：VDDT（Vinorelbine，Liposomal doxorubicin or mitoxantrone ，Dexamethasone and Thalidomide）：repeated every 14 days ，up to 12 cycles
Drug: Chidamide
30mg , Oral twice a week(with an interval of no less than 3 days,;e.g. Monday and Thursday，Tuesday and Friday) until disease progression or unacceptable toxicity develops
Drug: Vinorelbine
20mg/m2， IV on day 1 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
Drug: Liposomal Doxorubicin or mitoxantrone
20mg/m2, IV on day 1 of each 14 day cycle（Note：for patients who can not afford the liposomal doxorubicin，may be replaced into mitoxantrone 8mg/m2, IV on day1 of each 14 day cycle） until disease progression or unacceptable toxicity develops, up to 12 cycles
Drug: Dexamethasone
10mg/m2 , IV on day 1-5 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
Drug: Thalidomide
100mg,Oral at night on each day until disease progression or unacceptable toxicity develops, up to 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: every 8 weeks until 1 year after last patient's enrollment
the total proportion of patients with complete response（CR or CRu）and partial response（PR）
every 8 weeks until 1 year after last patient's enrollment
adverse events
Time Frame: from the date of first cycle of treatment to 1 year after last patient's enrollment
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
from the date of first cycle of treatment to 1 year after last patient's enrollment
abnormal laboratory examinations
Time Frame: from the date of first enrollment to 1 year after last patient's enrollment
includes type, incidence, relationship with treatment and severity of abnormal laboratory examinations.
from the date of first enrollment to 1 year after last patient's enrollment
incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations
Time Frame: from the date of first cycle of treatment to 1 year after last patient's enrollment
the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03) and abnormal laboratory examinations
from the date of first cycle of treatment to 1 year after last patient's enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: from the day of treatment to the date of first documented progression，up to 1 year after last patient's enrollment
from date of first day of treatment to the date of first documented
from the day of treatment to the date of first documented progression，up to 1 year after last patient's enrollment
duration of response
Time Frame: from the day of first documented response to first documented progression or death，up to 1 year after last patient's enrollment
from the first day of documented response to disease progression or death.
from the day of first documented response to first documented progression or death，up to 1 year after last patient's enrollment

Collaborators and Investigators

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

Sponsor

Henan Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2016

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

March 25, 2016

First Submitted That Met QC Criteria

April 8, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNSZLYYML-01

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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