RecruitingPhase 2NCT05348213

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

Sponsor

Ruijin Hospital

Enrollment

76 participants

Start Date

May 16, 2022

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new targeted drug combinations alongside a standard chemotherapy regimen (R-ICE) for people with diffuse large B-cell lymphoma (DLBCL) — an aggressive type of blood cancer — that has come back or stopped responding to first-line treatment. **You may be eligible if...** - You are between 18 and 75 years old and have confirmed DLBCL - Your cancer has returned or did not respond to first-line treatment - You have measurable disease on a PET/CT scan - Your blood counts, liver, and kidney function meet the study requirements - You have a life expectancy of more than 3 months **You may NOT be eligible if...** - You have active hepatitis B, hepatitis C, or HIV - You have lymphoma that has spread to the brain or spinal cord - You have had a deep vein clot or pulmonary embolism in the last 12 months - You are pregnant or breastfeeding - You have had a serious heart condition or recently had major surgery - You have received an organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanubrutinib 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

DRUGDecitabine 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

DRUGChidamide 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

DRUGTofacitinib 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

DRUGPomalidomide 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

Locations(1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

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NCT05348213

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