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

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

Recruiting
16 years and older
All
Phase 2

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.

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

NCT05050630

Affiliated Hospital to Academy of Military Medical Sciences

21 September 2021

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