Status:
UNKNOWN
GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
Lead Sponsor:
Sun Yat-sen University
Conditions:
Lymphoma, Large B-Cell, Diffuse
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04021992
Start Date
July 15 2019
End Date
December 15 2023
Last Update
August 6 2019
Active Locations (1)
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1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000