NCT05050630

Phase II Trial of Tirelizumab Combined With R2-ICE Regimen in the Treatment of rrDLBCL/HGBL

A Perspective and Multicenter Phase II Trial of Tirelizumab Combined With R2-ICE Regimen (Rituximab, Lenalidomide, Ifosfamide, Carboplatin, Etoposide) in the Treatment of Refractory or Relapse DLBCL or HGBL

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study was a prospective, multi-center, single-arm, Phase II clinical study. Compared with the literature data, objective response rate (ORR) and complete response rate (CR) were the primary endpoint, and 1-year and 2-year progression-free survival (PFS) and 2-year overall survival (OS) were the secondary endpoint. To evaluate the efficacy and safety of TR2-ICE sequential Tirelarizin, lenalidomide alone, or both maintenance therapy in the rescue of patients with relapsed and refractory diffuse large B or high-grade B-cell lymphoma.

Detailed description

All patients eligible for inclusion were treated with TR2-ICE, and the first efficacy evaluation was conducted after the second course of treatment. If the patient can achieve complete response (CR), partial response (PR), and disease stability (SD), the clinical benefit is considered, and the TR2-ICE treatment regimen is continued. The second efficacy assessment was performed after the 4th course of treatment. If patients achieved complete response (CR) or partial response (PR) compared to baseline, the clinical treatment was considered effective and the TR2-ICE treatment regimen was continued. After the completion of six courses of induction chemotherapy, an end-of-course assessment was performed. Patients with CR and PR can choose to undergo autologous hematopoietic stem cell transplantation consolidation therapy, or lenalidomide or Tirelarizin monotherapy or both combination maintenance therapy. If patients still had SD after four courses of treatment or PD at any time during the study, they were dropped out of the study and given salvage therapy.

Conditions

• Age Range ≥16 Years, Gender Unlimited
• Histopathology Confirmed Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma
• Received Prior First-line Chemotherapy for DLBCL or HGBL, Failed to Reach CR for Four Cycles, or Relapsed
• At Least One Positive Lesion According to the 2014 Lugano Criteria for Hodgkin's and Non-Hodgkin's Lymphoma
• ECOG Physical Status Score is 0-3
• The Researchers Judged That Life Expectancy Was at Least Three Months
• Understand and Voluntarily Sign Written Informed Consent

Interventions

Type	Name	Description
DRUG	TR2-ICE	Rituximab 375 mg/m2 d0; Lenalidomide 25mg/d d1-10; Ifosfamide 5g/m2 d2; Carboplatin calculate according to AUC=5 (single dose ≤800 mg); Etoposide 100mg/m2 d1-3; Tirelizumab 200mg d6.

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-07-30
• Completion: 2023-07-30
• First posted: 2021-09-20
• Last updated: 2021-09-20

Locations

1 site across 1 country: China