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Bortezomib Maintenance in High Risk DLBCL

NCT01965977 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-10-23

No results posted yet for this study

Summary

This study is an Open-labeled, multicenter Phase II study of Bortezomib for maintenance therapy in patients with high risk diffuse large B cell lymphoma (DLBCL). Primary objective is 3 years relapse free survival (RFS) and Secondary objectives are 3 years overall survival (OS), 3 years event free survival (EFS),Toxicities profiles, Quality of Life (FACT\&GOG-Ntx)

Conditions

Interventions

DRUG

Bortezomib

Bortezomib 1.3mg/m2, on day 1 and 15 SC Repeat every month for 12months

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Wonseog Kim, M.D., Ph.D. · Samsung Medical Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-08
Primary Completion
2018-10-30
Completion
2021-10-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01965977 on ClinicalTrials.gov