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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphoma, Large B-Cell, Diffuse

Intervention / Treatment
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* Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GVD with or without R<br>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<br>* All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR |  | 4-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rates in autologous stem cell mobilization |  | 4-years | 
| PFS |  | 4-years | 
| EFS |  | 4-years | 
| OS |  | 4-years |