A single-center, open, single-arm clinical study of the efficacy and safety of a novel targeted agent in combination with R-ICE in the treatment of relapsed and refractory diffuse Large B-cell lymphoma.
Refractory recurrence of patients with diffuse large B cell lymphoma inclusion/exclusion standard subjects in a signed written informed consent, according to the results of genotyping, divided the patients into MCD, TP53, BN2, EZB, ST2, NOS, N1, a total of 7 kinds of types. New targeted drugs were added based on typing results: Zanubrutinib for MCD and BN2, Decitabine for TP53, Chidamide for EZB, Tofacitinib for ST2, and Pomalidomide for N1 and NOS. After 3 courses of treatment, PET-CT was used to evaluate the efficacy. Patients with CR/PR, aged ≤65 years, qualified and willing for transplantation, were treated with autologous hematopoietic stem cell transplantation (ASCT); Patients who did not meet the above requirements or failed to collect autologous hematopoietic stem cells were placed on new targeted drug maintenance therapy for up to 12 months; If patients were evaluated as SD and PD after 3 cycles, they were treated with other regiments. New targeted drugs combined with R-ICE and ASCT were evaluated every 3 months in the first year and every 6 months in the second and third years after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Zanubrutinib 160mg/bid PO D1-21 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\[GFR(ml/min) + 25\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3
Decitabine 10mg/m2 IV D1-5 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\[GFR(ml/min) + 25\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3
Chidamide 20mg/d PO D1、4、8、11 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\[GFR(ml/min) + 25\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGComplete response rate after 3 cycle chemotherapy
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: At the end of cycle 3 (each cycle is 21 days)
Objective remission rate after 3 cycle chemotherapy
Percentage of participants with complete response or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: At the end of cycle 3 (each cycle is 21 days)
2 year progression free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
2 year overall survival
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Chemotherapy-related adverse reactions
Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment.
Time frame: At the end of cycle 3 (each cycle is 21 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tofacitinib 5mg/bid PO D1-10 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\[GFR(ml/min) + 25\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3
Pomalidomide 4mg/d PO D1-10 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\[GFR(ml/min) + 25\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3