Back to resultsGVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
Primary Purpose
Lymphoma, Large B-Cell, Diffuse
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse
Eligibility 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.
Sites / Locations
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GVD with or without R
Arm Description
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.
Outcomes
Primary Outcome Measures
ORR
Secondary Outcome Measures
success rates in autologous stem cell mobilization
PFS
EFS
OS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04021992
Brief Title
GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GVD with or without R
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
Intervention Description
All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.
Primary Outcome Measure Information:
Title
ORR
Time Frame
4-years
Secondary Outcome Measure Information:
Title
success rates in autologous stem cell mobilization
Time Frame
4-years
Title
PFS
Time Frame
4-years
Title
EFS
Time Frame
4-years
Title
OS
Time Frame
4-years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cai, MD
Phone
0086-20-87342823
Email
caiqq@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihua LI, MD
12. IPD Sharing Statement
Learn more about this trial
GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
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