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出境医 / 临床实验 / Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL

Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL

Study Description
Brief Summary:
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : September 15, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Chidamide combined with R-GemOx
Chidamide, 20 mg,twice per week; Rituximab 375mg/m2, d1, intravenous drip; Gemcitabine 1000mg/m2, d2, intravenous drip; Oxaliplatin 100mg/m2, d2,intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive chidamide maintenance therapy.
 Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin

All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy.

Patients with CR or PR will receive chidamide maintenance therapy.
Outcome Measures
Primary Outcome Measures :
  1. ORR [ Time Frame: 4-years ]

Secondary Outcome Measures :
  1. DOR [ Time Frame: 4-years ]
  2. DFS [ Time Frame: 4-years ]
  3. OS [ Time Frame: 4-years ]

Other Outcome Measures:
  1. bio-marker analysis [ Time Frame: 4-years ]
    Correlation between epigenetic factor mutation and efficacy


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:

  • biopsy proved CD20+ DLBCL;
  • first relapse or refractory；
  • previously received systemic chemotherapy with anthracycline；
  • not eligible for autologous hematopoietic stem cell transplantation；
  • at least one evaluable lesion；
  • ECOG PS 0-1;
  • 18-75 years; without other malignancy;
  • proper functioning of the major organs.

Exclusion Criteria:

  • double-hit lymphoma;
  • previously received treatment of HDAC inhibitor;
  • plan to receive autologous stem cell transplantation;
  • involvement of central nervous system;
  • previously received more than one chemotherapy regimen;
  • patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Qingqing Cai, MD 0086-20-87342823 caiqq@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 51000
Contact: ZHIHUA LI, MD         
Sponsors and Collaborators
Sun Yat-sen University
Tracking Information
First Submitted Date  ICMJE July 13, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date July 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2019) 		ORR [ Time Frame: 4-years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2019)
  • DOR [ Time Frame: 4-years ]
  • DFS [ Time Frame: 4-years ]
  • OS [ Time Frame: 4-years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2019) 		bio-marker analysis [ Time Frame: 4-years ]
Correlation between epigenetic factor mutation and efficacy
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL
Official Title  ICMJE Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study
Brief Summary The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Large B-Cell, Diffuse
Intervention  ICMJE Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin

All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy.

Patients with CR or PR will receive chidamide maintenance therapy.
Study Arms  ICMJE Experimental: Chidamide combined with R-GemOx
Chidamide, 20 mg,twice per week; Rituximab 375mg/m2, d1, intravenous drip; Gemcitabine 1000mg/m2, d2, intravenous drip; Oxaliplatin 100mg/m2, d2,intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive chidamide maintenance therapy.
Intervention: Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2019) 		54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2023
Estimated Primary Completion Date July 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • biopsy proved CD20+ DLBCL;
  • first relapse or refractory；
  • previously received systemic chemotherapy with anthracycline；
  • not eligible for autologous hematopoietic stem cell transplantation；
  • at least one evaluable lesion；
  • ECOG PS 0-1;
  • 18-75 years; without other malignancy;
  • proper functioning of the major organs.

Exclusion Criteria:

  • double-hit lymphoma;
  • previously received treatment of HDAC inhibitor;
  • plan to receive autologous stem cell transplantation;
  • involvement of central nervous system;
  • previously received more than one chemotherapy regimen;
  • patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qingqing Cai, MD 0086-20-87342823 caiqq@sysucc.org.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04022005
Other Study ID Numbers  ICMJE B2019-091
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qingqing Cai, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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