Overview

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.