To evaluate the efficacy and safety of CAGM regimen in R/R DLBCL patients and to provide a safe and more effective approach for R/R DLBCL patients.
The study will start with an initial 2 cycles of induction therapy with CAGM containing chidamide, azacitidine, obinutuzumab and mitoxantrone liposome, orelabrutinib and rituximab,following imaging examinations to evaluate response rates. For patients feasible to CAR-T/ASCT, sequential CAR-T/ASCT treatment was given. For patients who were unable to undergo CAR-T/ASCT, 4 cycles of CAGM immunochemotherapy were carried out. Efficacy and safety of CAGM regimen in R/R DLBCL will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
20 mg (4 capsules), d1, d4, d8, d11 orally per cycle
100mg d1- d5 subcutaneous injection per cycle
1000mg d4 intravenous infusion per cycle
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall response rate(ORR)
The rate of patients who achieved CR or PR after treatment by CAGM regimen
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Complete response rate(CRR)
The rate of patients who achieved CR after treatment by CAGM regimen
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
The safety and tolerability of the therapeutic regimen measured by the incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events.
Time frame: initiation of study drug until 30 days after last dose
Progression-free survival(PFS)
PFS will be assessed from the first CAGM given to date of progression, relapse, death or end of follow-up.
Time frame: Up to 24 months after the end of last patients' treatment.
Overal survival(OS)
OS will be assessed from the first CAGM given to date of death or end of follow-up.
Time frame: Up to 24 months after the end of last patients' treatment.
Overall response rate(ORR)
The rate of patients who achieved CR or PR after treatment by CAGM regimen
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Complete response rate(CRR)
The rate of patients who achieved CR after treatment by CAGM regimen
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20mg/m2 d5 intravenous infusion per cycle
Time frame: At the end of Cycle 6 (each cycle is 28 days)