As the most common subtype of lymphoma, diffuse large B-cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy. However, patients with early relapse (relapse within 12 months since diagnosis or the end of first-line treatment, ER) or primary refractory had an even worse prognosis. Thus, the investigators plan to evaluate the efficacy and safety of anlotinib combined with rituximab, gemcitabine, oxaliplatin (A-RGEMOX) in the treatment of early relapsed/refractory diffuse large B-cell lymphoma.
Diffuse large B-cell lymphoma (DLBCL), the most common subtype of lymphoma, accounts for about 30%-40% of non-Hodgkin's lymphomas and is highly heterogeneous in terms of clinical presentation and biological behavior. About 10% of patients are resistant to first-line immunochemotherapy, and up to 30%-40% of patients will relapse after treatment. Patients with relapsed/refractory (R/R) DLBCL showed poor prognosis, with a median overall survival of only 6.3 months. Those with early relapse (relapse within 12 months since diagnosis or the end of first-line treatment, ER) or primary refractory had an even worse prognosis. So there is an unmet need for treatment in this population. Previous reports and our unpublished data showed the potential connection between angiogenesis and first-line treatment failure. Accordingly, we assume that the combination of anlotinib and RGEMOX regimen may improve the response rate of patients with early relapsed/refractory DLBCL, increasing the feasibility of follow-up ASCT, and improving long-term survival of this subgroup of patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Anlotinib: 12mg d1\~14 po qd, Rituximab: 375mg/m2 d1, gemcitabine: 1000mg/m2 d1 and d8, oxaliplatin: 130mg/m2 d1; For subjects ≥75 years of age, appropriate reduction of chemotherapy drugs (not less than 75% of the standard dose, or withdrawal of day 8 gemcitabine) may be decided by the investigator.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGCRR
Complete Remission Rate
Time frame: 21days after the end of treatment
ORR
overall response rate
Time frame: 21days after the end of treatment
PFS
Progression Free Survival
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
OS
Overall Survival
Time frame: From date of enrollment until the date of first documented date of death from any cause, assessed up to 5 years
PRR
Partial Remission Rate
Time frame: 21days after the end of treatment
AE and SAE
Adverse event and serious adverse event
Time frame: From date of first day of treatment until 30 day after last treatment
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