Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

December 12, 2017 updated by: Kai Xue, MD, Fudan University

A Non-randomized, Open-label, Phase II Study of Chidamide Combined With R-GDP in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Not Suitable for Transplantation

The goal of this clinical trial is to evaluate therapeutic efficacy of Chidamide combined with R-GDP （rituximab/gemcitabine/dexamethasone/cisplatin）in treating Patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The treatment outcome of patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) are not satisfactory especially for those not suitable for transplantation. One of main reason is chemotherapy resistance. The investigators conducted this study to evaluate the efficacy of Chidamide combined with R-GDP(rituximab/gemcitabine/dexamethasone/cisplatin) in treating patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation. Chidamide is a novel benzamide type of subtype-selective histone deacetylase (HDAC) inhibitor. It has been approved by China Food and Drug Administration (CFDA) for treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) in Chinese population. The investigators' pre-clinical data suggested that this agent might be also efficient in the treatment of relapsed/refractory B cell lymphoma. In this open-label, non-randomized, phase II study, the investigators aimed to observe the efficacy and safety of chidamide combined with R-GDP in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) not suitable for transplantation.

Study Type

Interventional

Enrollment (Anticipated)

63

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
      • Shanghai, China
        • Recruiting
        • Kai Xue
        • Contact:
        • Contact:
          • Junning Cao, MD
          • Phone Number: 13818659448
    • Shanghai
      • Shanghai, Shanghai, China, 200032

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. Ages: 18-75 years old
  2. Relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) previous treated with standard chemoimmunotherapy
  3. Not willing or not suitable for hematopoietic stem cell transplantation (HSCT)
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) index < 2
  5. Informed consent available
  6. Life expectancy of more than 3 months;
  7. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
  8. Bone marrow function: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, Hb ≥ 80g/L;
  9. Liver function: total bilirubin, ALT and AST were <1.5 × UNL (the upper limit of normal value)
  10. Renal function: Cr<1.5 × UNL and creatinine clearance > 50ml/min

Exclusion Criteria:

  1. Prior history of treatment of HDAC inhibitor.
  2. Plan of HSCT in the future
  3. Significant pericardial effusion showed by chest CT scan
  4. Prior history of other cancers except treated cervical or basal cell skin carcinoma, organ transplantation
  5. Syphilis or human immunodeficiency virus (HIV) infection
  6. Pregnant or lactating women
  7. History of organ transplantation
  8. Serious active infections (including hepatitis)
  9. Serious neurological or psychiatric history, including dementia or epilepsy.

Termination criteria:

  1. Withdrew consent
  2. Researchers think it is necessary to terminate the study;
  3. Disease progression or death;
  4. Poor compliance
  5. Subclinical or clinical cardiac toxicity;
  6. Unable to continue treatment because of severe toxicity

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chidamide combined with R-GDP
Chidamide: 30mg,PO,biw one week before cycle 1 treatment rituximab 375 mg/m2,ivgtt D0 gemcitabine 1000mg/m2 iv D1,8 dexamethasone 40mg, iv D1-4, cisplatin 25mg/m2 iv D1-4 chidamide :20mg PO Biw, 2 week on , 1 week off
Drug: Chidamide combined with R-GDP
Chidamide: 30mg,PO,biw one week before cycle 1 treatment rituximab 375 mg/m2,ivgtt D0 gemcitabine 1000mg/m2 iv D1,8 dexamethasone 40mg, iv D1-4, cisplatin 25mg/m2 iv D1-4 chidamide :20mg PO Biw, 2 week on , 1 week off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 6 weeks
overall response rate
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 3 years
overall survival
3 years
3 year PFS
Time Frame: 3 years
3 year progression free survival
3 years
adverse event
Time Frame: throughout the treatment period，up to 6 months
adverse event related to treatment
throughout the treatment period，up to 6 months
CR
Time Frame: 6 weeks
complete response
6 weeks

Collaborators and Investigators

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

Sponsor

Fudan University

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)

December 21, 2017

Primary Completion (ANTICIPATED)

June 30, 2019

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (ACTUAL)

December 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-RD1

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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