GlioblastomaNCT01653834
Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
A study testing Lymphocyte harvesting & reinfusion in people with Glioblastoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Lymphocyte harvesting & reinfusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- Lymphocyte harvesting & reinfusion
- Keywords
- lymphopenia
- Medical subject headings
- Glioblastoma, Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphocyte harvesting & reinfusionProcedure or surgery
Lymphocytes will be collected and stored approximately one week prior to initiating concurrent radiation therapy (RT) and temozolomide (TMZ). Two lymphocyte collections are allowed. After the patient has completed 6 weeks of RT/TMZ, all of the collected lymphocytes will be re-infused. After lymphocyte re-infusion, Heme-8 and absolute lymphocyte count (ALC) will be checked per standard of care. The absolute increase in ALC as the primary endpoint will be assessed 4 weeks after lymphocyte re-infusion.
| Study group | Role | What they receive |
|---|---|---|
| Lymphocyte harvesting & reinfusion | Experimental | Patients with a newly diagnosed high grade glioma (Grade III or IV), have a post-operative treatment plan that includes standard radiation and temozolomide, and have normal bone marrow function with Hematocrit ≥ 30%, platelet ≥ 100K, ANC ≥ 1000, and absolute lymphocyte count ≥ 1000 prior entry to this study are eligible for enrollment. Receives: Procedure: Lymphocyte harvesting & reinfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
the feasibility of lymphocyte harvesting and reinfusion
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.
Measured: 10 weeks
Secondary outcomes (3)
the number of lymphocytes that can be harvested in this pt population
the number of lymphocytes harvested per patient
Measured: 10 weeks
duration of lymphocyte rise following lymphocyte reinfusion
how long will lymphocyte counts remain elevated after reinfusion
Measured: 10 weeks
changes in lymphocyte subtypes following collection and reinfusion
changes in lymphocyte subtype between collection and reinfusion as a result of freezing for storage.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart A Grossman, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653834
- Sponsor's protocol ID
- J11162
- Other IDs
- NA_00068991
- Status last verified
- Nov 2018
- First submitted
- 12 Jul 2012
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas
- ClinicalTrials.gov ID
- NCT01653834
- Acronym / sponsor ID
- J11162
- Conditions
- Glioblastoma
- Keywords
- lymphopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphocyte harvesting & reinfusion | Experimental | Procedure: Lymphocyte harvesting & reinfusionPatients with a newly diagnosed high grade glioma (Grade III or IV), have a post-operative treatment plan that includes standard radiation and temozolomide, and have normal bone marrow function with Hematocrit ≥ 30%, platelet ≥ 100K, ANC ≥ 1000, and absolute lymphocyte count ≥ 1000 prior entry to this study are eligible for enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Age≥18 year
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphocyte harvesting & reinfusionLymphocytes will be collected and stored approximately one week prior to initiating concurrent radiation therapy (RT) and temozolomide (TMZ). Two lymphocyte collections are allowed. After the patient has completed 6 weeks of RT/TMZ, all of the collected lymphocytes will be re-infused. After lymphocyte re-infusion, Heme-8 and absolute lymphocyte count (ALC) will be checked per standard of care. The absolute increase in ALC as the primary endpoint will be assessed 4 weeks after lymphocyte re-infusion. | Procedure or surgery | Lymphocyte harvesting & reinfusion |
Primary outcome
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.
3 secondary outcomes
the number of lymphocytes that can be harvested in this pt population
Time frame: 10 weeks
duration of lymphocyte rise following lymphocyte reinfusion
Time frame: 10 weeks
changes in lymphocyte subtypes following collection and reinfusion
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart A Grossman, MD study chair
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphocyte harvesting & reinfusion in people with Glioblastoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the feasibility of lymphocyte harvesting and reinfusion (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.