This phase 2 trial studies the efficacy and safety of PD-1 inhibitor monotherapy or PD-1 inhibitor with GVD (Gemcitabine, Vinorelbine and Doxorubicin Liposome) regimen for relapsed or refractory classical Hodgkin lymphoma (CHL) patients who failed the first-line induction therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
PD-1 Inhibitor, intravenous drip, d1.
PD-1 Inhibitor, intravenous drip, d1; Gemcitabine, 1000mg/m2, intravenous drip, d1,d8; Vinorelbine, 50mg/m2, PO, d1,d8; Doxorubicin Liposome, 30mg/m2, intravenous drip, d1;
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
RECRUITINGComplete remission rate
Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: 2 years
Objective Response rate
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: 2 years
Progression Free Survival
The time from the start of treatment to the progression of the tumor or death (due to any cause).
Time frame: 5 years
Overall Survival
The time from the start of treatment to time of death (due to any cause).
Time frame: 5 years
Duration of Response
The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).
Time frame: 5 years
Time to Response (TTR)
The time from the start of treatment to the first assessment of complete remission or partial remission.
Time frame: 2 years
Percentage of Participants With Adverse Events
Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
Time frame: 2 years
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