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出境医 / 临床实验 / GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL

GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed 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 GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed diffuse large B-cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed 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 : December 15, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: GVD with or without R
Gemcitabine 1000mg/m2, d1,d8, intravenous drip; Vinorelbine 50mg/m2, d1,d8, oral; Doxorubicin liposomes 30mg/m2, d1,intravenous drip; With or without rituximab 375 mg/m2, d0,intravenous drip; All patients received up to 6 treatment cycles of 21 days.
 Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.
Outcome Measures
Primary Outcome Measures :
  1. ORR [ Time Frame: 4-years ]

Secondary Outcome Measures :
  1. success rates in autologous stem cell mobilization [ Time Frame: 4-years ]
  2. PFS [ Time Frame: 4-years ]
  3. EFS [ Time Frame: 4-years ]
  4. OS [ Time Frame: 4-years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • biopsy proved CD20+ DLBCL;
  • previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission;
  • at least one evaluable lesion；
  • ECOG PS 0-1;
  • 18-65 years;
  • proper functioning of the major organs.

Exclusion Criteria:

  • involvement of central nervous system;
  • with other malignancy;
  • patients receiving or received drug of other clinical trial within 30 days；
  • previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2)；
  • patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
  • grade 2 or more peripheral neuropathy.
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, 510000
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)
  • success rates in autologous stem cell mobilization [ Time Frame: 4-years ]
  • PFS [ Time Frame: 4-years ]
  • EFS [ Time Frame: 4-years ]
  • OS [ Time Frame: 4-years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
Official Title  ICMJE GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed 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 GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed 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: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.
Study Arms  ICMJE Experimental: GVD with or without R
Gemcitabine 1000mg/m2, d1,d8, intravenous drip; Vinorelbine 50mg/m2, d1,d8, oral; Doxorubicin liposomes 30mg/m2, d1,intravenous drip; With or without rituximab 375 mg/m2, d0,intravenous drip; All patients received up to 6 treatment cycles of 21 days.
Intervention: Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
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) 		48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 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;
  • previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission;
  • at least one evaluable lesion；
  • ECOG PS 0-1;
  • 18-65 years;
  • proper functioning of the major organs.

Exclusion Criteria:

  • involvement of central nervous system;
  • with other malignancy;
  • patients receiving or received drug of other clinical trial within 30 days；
  • previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2)；
  • patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
  • grade 2 or more peripheral neuropathy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 NCT04021992
Other Study ID Numbers  ICMJE B2019-088
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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