CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 76 target
Drug / intervention
Zanubrutinib plus R-ICE +4 moredrug
Likely dose
Zanubrutinib plus R-ICE 160mgfrom record
Key inclusion· 7
  • Histologically confirmed DLBCL per WHO classification
  • Evaluable lesions on PET/CT
  • Life expectancy >3 months
  • Relapsed/refractory disease: no remission within 90 days of first-line therapy or progression after first-line therapy, with ≥2 weeks washout
Key exclusion· 11
  • Pregnant or lactating women
  • Hepatitis B (HBV-DNA >detectable limit) or Hepatitis C (HCV) infection
  • HIV infection or other acquired/congenital immune deficiency disorders
  • History of DVT or PE within past 12 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05348213
NCT05348213Phase 2RecruitingUpdate OverdueUpdated 20mo ago · Completion was 13mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

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

Ruijin Hospital·interventional·Posted Apr 27, 2022·Updated Oct 23, 2024

In Brief

A Phase 2 clinical trial evaluating Zanubrutinib plus R-ICE, Decitabine plus R-ICE, and 3 other interventions for Diffuse Large B Cell Lymphoma. Currently recruiting, targeting 76 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2RecruitingOverdue
2023202420252026
First PostedApr 27, 2022
Enrollment StartMay 16, 2022
Primary CompletionJun 1, 2025
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.2 years ago

Interventions

Zanubrutinib plus R-ICEdrug

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-ICEdrug

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-ICEdrug

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-ICEdrug

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-ICEdrug

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