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

Sponsor
Ruijin Hospital
Study ID
NCT05348213
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib plus R-ICE — DRUG
    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 plus R-ICE — DRUG
    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 plus R-ICE — DRUG
    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
  • Tofacitinib plus R-ICE — DRUG
    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 plus R-ICE — DRUG
    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

Study Details

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.

Key Dates

Start date
May 16, 2022
Status verified
Oct 2024
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
76 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-ICE+X
    R-ICE plus novel targeted drugs

Primary Outcome Measure

Complete response rate after 3 cycle chemotherapy [ Time Frame: At the end of cycle 3 (each cycle is 21 days) ]

Central Contacts

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