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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04021992

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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

Study Type:

Interventional

Anticipated 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 :

Jul 15, 2019

Anticipated Primary Completion Date :

Jul 15, 2023

Anticipated Study Completion Date :

Dec 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.

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

ORR [4-years]

Secondary Outcome Measures

success rates in autologous stem cell mobilization [4-years]
PFS [4-years]
EFS [4-years]
OS [4-years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.