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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Lymphoma, Large B-Cell, Diffuse

Treatments: Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT04021992

B2019-088

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

GVD with or without R

Experimental group

Description:

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.

Treatment:

Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab