GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2019
CompletedStudy Start
First participant enrolled
July 15, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedAugust 6, 2019
August 1, 2019
4 years
July 13, 2019
August 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
4-years
Secondary Outcomes (4)
success rates in autologous stem cell mobilization
4-years
PFS
4-years
EFS
4-years
OS
4-years
Study Arms (1)
GVD with or without R
EXPERIMENTALGemcitabine 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.
Interventions
All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.
Eligibility Criteria
You may qualify if:
- 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;
- years;
- proper functioning of the major organs.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
July 13, 2019
First Posted
July 16, 2019
Study Start
July 15, 2019
Primary Completion
July 15, 2023
Study Completion
December 15, 2023
Last Updated
August 6, 2019
Record last verified: 2019-08