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

NCT05050630 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2021-09-20

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Affiliated Hospital to Academy of Military Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-07-30
Completion
2023-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05050630 on ClinicalTrials.gov