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

• Status: Recruiting
• Trial end date: 2023-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Doxorubicin; Gemcitabine; Liposomal doxorubicin; Rituximab; Vinorelbine

Criteria

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.