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Lymphocyte Reinfusion

This study has been completed.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: July 12, 2012
Last updated: August 11, 2014
Last verified: August 2014
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.

Condition Intervention
Glioblastoma Biological: Harvesting and reinfusion of autologous lymphocytes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • the number of lymphocytes that can be harvested in this pt population [ Time Frame: 10 weeks ]
    the number of lymphocytes harvested per patient

  • duration of lymphocyte rise following lymphocyte reinfusion [ Time Frame: 10 weeks ]
    how long will lymphocyte counts remain elevated after reinfusion

  • changes in lymphocyte subtypes following collection and reinfusion [ Time Frame: 10 weeks ]
    changes in lymphocyte subtype between collection and reinfusion as a result of freezing for storage.

Enrollment: 10
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: all pts with lymphocyte harvesting and reinfusion
pts will be treated with standard temozolmide and radiation, prior to treatment will have lymphocytes harvested (collected and stored) and at week 10 pts lymphocytes will be re-infused. Lymphocyctes will be checked weekly for 14weeks until week 20
Biological: Harvesting and reinfusion of autologous lymphocytes
collect lymphocytes prior to pts starting RT/chemo and put them back after pt completes RT

Detailed Description:

The patients blood will be collected (apheresis) before starting the patients planned standard of care radiation therapy and chemotherapy:

  • An IV will be inserted into the vein in the patients arm.
  • The blood will be sent to a machine that removes the lymphocytes and returns the rest to the patient.
  • This procedure will last from 1 hour and 15 minutes to 4 hours.
  • During this time the patient will also be treated with a blood thinner to prevent the blood from clotting in the machine.
  • The lymphocytes will be counted and stored. If an insufficient number were collected, we will ask for another similar collection in about 1 week.
  • After the patient has completed the full 6 weeks of radiation, all of the lymphocytes will be returned to the patient through a simple intravenous infusion. A larger intravenous access (i.e. midline) might be needed. Any cells that are not reinfused will be stored for 1 year and then discarded.
  • Study bloods (10 ml) will be collected at the time of lymphocyte collection, prior lymphocyte reinfusion, and then every 2 weeks until week 20th. These blood samples will be stored and used for future analysis.

Blood counts are obtained weekly as part of standard care for patients with this kind of brain tumor. For the first 14 weeks after the lymphocyte reinfusion we will be doing some extra tests on the routinely collected blood to see how the effective the reinfused lymphocytes are in raising the patients lymphocyte counts. These results will be available to the patients treating physician.

At no time will this study interfere with the patients planned standard of care radiation and chemotherapy.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • • Age≥18 year

    • New diagnosed high grade glioma
    • Post-operative treatment with standard RT/TMZ
    • Karnofsky performance status ≥ 60%
    • Normal bone marrow function with Hematocrit ≥ 30%, platelet ≥ 100K, ANC ≥ 1000, and absolute lymphocyte count ≥ 1000 prior entry to this study. Blood product transfusions are allowed.

Exclusion Criteria:

  • Prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents or hormonal therapy for their brain tumor are excluded. Glucocorticoid therapy is allowed.
  • Fresh CNS bleed, current anticoagulation use; and anti-VEGF therapy in past 6 weeks are excluded.
  • Patients must not have taken an ACE inhibitor within last 24 hours prior to apheresis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01653834

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT01653834     History of Changes
Other Study ID Numbers: J11162
NA_00068991 ( Other Identifier: JHMIRB )
Study First Received: July 12, 2012
Last Updated: August 11, 2014

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue processed this record on August 18, 2017