GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL

Phase 2

• Conditions: Lymphoma, Large B-Cell, Diffuse
• Interventions: Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab

• Registration Number: NCT04021992
• Lead Sponsor: Sun Yat-sen University

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 available

Study Timeline

• Study First Submitted: 2019-07-13
• Study First Submitted QC: 2019-07-13
• Study Start: 2019-07-15
• Study First Posted: 2019-07-16
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-03
• Last Update Posted: 2019-08-06
• Primary Completion: 2023-07-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GVD with or without R	gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab	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.

Primary Outcome Measures

Name	Time	Method
ORR	4-years

Secondary Outcome Measures

Name	Time	Method
PFS	4-years
EFS	4-years
success rates in autologous stem cell mobilization	4-years
OS	4-years

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China