NCT01653834

Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas

Completed NA Last updated 5 November 2018

What this trial tests

NA trial testing Lymphocyte harvesting & reinfusion in Glioblastoma in 10 participants. Completed in 1 March 2014.

Timeline

1 July 2012

Primary endpoint
1 January 2014

1 March 2014

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 July 2012
Primary completion	1 January 2014
Estimated completion	1 March 2014
Sites	1 location across United States

Drugs / interventions tested

• Lymphocyte harvesting & reinfusion

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• the feasibility of lymphocyte harvesting and reinfusion
  Time frame: 10 weeks
  this will be considered a feasible approach if 5 of the 10 patients to be accrued have an absolute lymphocyte count increase of 300 cells per mm3 at 4 weeks after reinfusion.

Sponsor's own description

This research study is being done to see if lymphocytes can be collected from patients with high grade gliomas before they start standard radiation and chemotherapy. (Lymphocytes are cells that normally circulate in the blood and are an essential part of the immune system). The investigators goal is to store these and give them back to the patient after radiation is completed. This is part of a larger effort that will attempt to preserve the immune system from the effects of radiation and chemotherapy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lymphocyte-Sparing Radiotherapy: The Rationale for Protecting Lymphocyte-rich Organs When Combining Radiotherapy With Immunotherapy.
   Lambin P, Lieverse RIY, Eckert F, Marcus D, et al · · 2020 · cited 84× · PMID 32381298 · DOI 10.1016/j.semradonc.2019.12.003
2. Infusion of cryopreserved autologous lymphocytes using a standard peripheral i.v. catheter.
   Gladstone DE, Davis-Sproul J, Campian J, Lemas MV, et al · · 2014 · cited 2× · PMID 24842526 · DOI 10.1038/bmt.2014.98