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

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ClinicalTrials.gov Identifier: NCT03373019
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Kai Xue, MD, Fudan University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chidamide Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasm by Histology Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Rituximab Gemcitabine Cisplatin Dexamethasone HDAC Inhibitor Drug: Chidamide combined with R-GDP Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 21, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. ORR [ Time Frame: 6 weeks ]
    overall response rate


Secondary Outcome Measures :
  1. CR [ Time Frame: 6 weeks ]
    complete response

  2. OS [ Time Frame: 3 years ]
    overall survival

  3. 3 year PFS [ Time Frame: 3 years ]
    3 year progression free survival

  4. adverse event [ Time Frame: throughout the treatment period，up to 6 months ]
    adverse event related to treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373019


Contacts
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Contact: Kai Xue, MD 13818659448 xuekaishanghai@126.com

Locations
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China, Shanghai
Kai Xue Recruiting
Shanghai, Shanghai, China, 200032
Contact: Kai Xue, MD    13818659448    xuekaishanghai@126.com   
China
Kai Xue Recruiting
Shanghai, China
Contact: Kai Xue, MD    13818659448    xuekaishanghai@126.com   
Contact: Junning Cao, MD    13818659448      
Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: Kai Xue, MD, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT03373019     History of Changes
Other Study ID Numbers: CC-RD1
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kai Xue, MD, Fudan University:
chidamide
R-GDP
diffuse large B-cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Disease
Neoplasms
Immune System Diseases
Neoplasms by Histologic Type
Pathologic Processes