Prospective Evaluation of T-cell Immune Status in Patients With Newly

Status Completed

Clinical Trial Summary

The primary goal of this study is evaluate T cell immune status and immune reconstitution and the association with specific cytokines in patients with newly diagnosed HGGs undergoing the standard RT/TMZ and adjuvant TMZ.

Clinical Trial Description

Numbers of T-cell subtypes at six time points in patients with newly diagnosed HGGs undergoing standard RT/TMZ and adjuvant TMZ:

1. Baseline within 2 weeks before initiation of RT/TMZ

2. At the end of RT/TMZ approximately week 6

3. Before adjuvant TMZ approximately week 10

4. After 2 cycle of TMZ approximately week 18

5. After 4 cycle of TMZ approximately week 26

6. Three month after last cycle of TMZ

Secondary Endpoints

1. Changes in serial T cell subtypes and cytokines levels

2. Incidence of lymphopenia related infections

3. Changes in T-cell numbers and subtypes with TMZ administration

4. Overall survival ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02041611
Study type	Interventional
Source	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact
Status	Completed
Phase	N/A
Start date	July 13, 2012
Completion date	December 17, 2015

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Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms