Lymphoma, Large B-Cell, Diffuse
Conditions
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.
Interventions
DRUGgemcitabine, 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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR | 4-years |
Secondary
| Measure | Time frame |
|---|---|
| success rates in autologous stem cell mobilization | 4-years |
| PFS | 4-years |
| EFS | 4-years |
| OS | 4-years |
Countries
China
Contacts
Primary ContactQingqing Cai, MD
Outcome results
None listed