NCT05348213

Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma

Clinical Study of Efficacy and Safety of Novel Targeted Drugs Combined With R-ICE Regimen in the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Zanubrutinib plus R-ICE	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
DRUG	Decitabine plus R-ICE	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
DRUG	Chidamide plus R-ICE	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
DRUG	Tofacitinib plus R-ICE	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
DRUG	Pomalidomide plus R-ICE	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

Timeline

• Start date: 2022-05-16
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2022-04-27
• Last updated: 2024-10-23

Locations

1 site across 1 country: China