Hodgkin DiseasePhase 1ANGELANCT00058773
Giving Gene Marked EBV Specific T-Cells to Patients Receiving a BMT for Relapsed EBV-Positive Hodgkin Disease
A Phase 1 study testing Infusion of EBV Specific Cytotoxic T-Lymphocytes in people with Hodgkin Disease and Non-Hodgkins Lymphoma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Subjects have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma, which has come back or not gone away after treatment, including the best treatment we know for relapsed Lymphoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hodgkin Disease, Non-Hodgkins Lymphoma
- What is being tested?
- Infusion of EBV Specific Cytotoxic T-Lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 1996to Aug 2006
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient with Hodgkin disease or non-Hodgkin Lymphoma, containing the EBV genome or antigen, receiving an autologous bone marrow transplant regardless of age or sex.
- Patients with tumor tissue EBV +ve.
- Patients with life expectancy >6 weeks.
- Patients with Karnofsky score of > 50.
- No severe intercurrent infection.
- Patient, parent/guardian able to give informed consent.
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- Patient with Bilirubin <2x normal, SGOT <3x normal, and ANC greater than 500mm
- Patients with creatinine <2x normal for age or creatinine clearance >2x normal for age.
- Patients should have been off other investigational therapy for one month prior to entry in this study.
Who cannot join
- Patients with a life expectancy of <6 weeks.
- Patients with an EBV positive Lymphoma secondary to an acquired or congenital immunodeficiency.
- Patients with a Karnofsky score less than or equal to 50.
- Patients with a severe intercurrent infection.
- Patients with a bilirubin >2x normal,SGOT >3x normal, or abnormal prothrombin time.
- Patients with a creatinine >2x normal for age or creatinine clearance <2x normal for age.
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- Patients with an ANC <500mm
- Patient, parent/guardian unable to give informed consent.
- Patients who have been on other investigational therapy within one month prior to entry in this study.
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. Women of childbearing potential must be on appropriate birth control for the duration of the study and 6 months after completion of the study. In addition, the male partner should use a condom.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Children's Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Administration of Autologous Neomycin Resistant Gene Marked EBV Specific Cytotoxic T-Lymphocytes as Therapy for Patients Receiving Autologous Bone Marrow Transplant for Relapsed EBV-Positive Lymphoma.
Subjects have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma, which has come back or not gone away after treatment, including the best treatment we know for relapsed Lymphoma. We are asking subjects to volunteer to be in a research study using Epstein Barr virus (EBV) specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been used successfully in children with other types of blood cancer caused by EBV after bone marrow transplantation.
Some patients with Hodgkin disease or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis of Lymphoma. EBV is often found in the cancer cells suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are very clever because they are able to hide from the body's immune system and escape destruction. We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells and give them back to subjects.
Read the detailed description
We will take 60-70 ml (12 teaspoonfuls) of blood from the subject. We will first make a B cell line called a lymphoblastoid cell line or LCL by infecting the subjects blood with a laboratory strain of EBV called B95. We will then use use this EBV infected cell line (which have been treated with radiation so that they cannot grow) as stimulator cells and mix it with more blood. This stimulation will train the T cells to kill EBV infected cells and result in the growth of an EBV specific T cell line. We will then test the T cells to make sure that they kill the EBV infected cells and not your normal cells and freeze them.
The cells will be thawed and injected into subjects over 10 minutes, after pretreatment with Tylenol and Benadryl. A total of two doses will be given two weeks apart. All of the treatments will be given at Texas Children's Hospital or The Methodist Hospital.
We will follow subjects in the clinic after the injections. At each visit about 10ml (2 teaspoonfuls) of blood will be taken every other week for 6 weeks after the injection and then every 3 months for 1 year to monitor the subjects blood chemistry and hematology.
To learn more about the way the T cells are working in the subjects body, an extra 40mls (8 teaspoons) of blood will be taken pre-infusion, 3-4 days post infusion (optional) and at 1, 2, 4 and 6 weeks post-infusion and then at 3, 6, 9, and 12 months. The blood may be drawn from the subjects central line at the time of their regular blood tests.
- Conditions
- Hodgkin Disease, Non-Hodgkins Lymphoma
- Being tested
- Infusion of EBV Specific Cytotoxic T-Lymphocytes
- Keywords
- Hodgkin disease, non-Hodgkins Lymphoma, bone marrow transplant
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of EBV Specific Cytotoxic T-LymphocytesDrug
EBV specific cytotoxic T-lymphocytes will be given by intravenous injection over 1-10 minutes.
Each patient will receive two injections, 14 days apart.
| Study group | Role | What they receive |
|---|---|---|
| CTL Administration | Experimental | Infusion of EBV Specific Cytotoxic T-Lymphocytes Receives: Drug: Infusion of EBV Specific Cytotoxic T-Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the safety of 2 IV injections of autologously derived EBV specific cytotoxic T-lymphocytes
The two injections will be given at day 0 and day 14. Three patients will be enrolled at the first dose level and followed for six weeks after the second dose (which will constitute a course) for evaluation of any critical toxicity.
Measured: 8 weeks
Secondary outcomes (1)
determine the survival, immunological efficacy and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.
During the course of the study the survival, immunological efficacy and anti-tumor activity of neomycin resistance gene marked EBV specific cytotoxic T-lymphocyte lines will also be studied. In order to get a reasonable insight into the anti-tumor activity and late toxicity the patients will be followed for additional six weeks.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2003 (estimated)
- Study startJan 1996
- Primary completionApr 2002
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Principal investigator, catherine bollard, Baylor College of Medicine
- Investigators
- Catherine Bollard, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058773
- Sponsor's protocol ID
- H-6422-ANGELA
- Other IDs
- ANGELA
- Acronym
- ANGELA
- Status last verified
- Nov 2012
- First submitted
- 11 Apr 2003
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Autologous Neomycin Resistant Gene Marked EBV Specific Cytotoxic T-Lymphocytes as Therapy for Patients Receiving Autologous Bone Marrow Transplant for Relapsed EBV-Positive Lymphoma.
- ClinicalTrials.gov ID
- NCT00058773
- Acronym / sponsor ID
- ANGELA / H-6422-ANGELA
- Conditions
- Hodgkin Disease, Non-Hodgkins Lymphoma
- Keywords
- Hodgkin disease, non-Hodgkins Lymphoma, bone marrow transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Jan 1996
- Primary completion
- Apr 2002 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 15 Apr 2003 (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.
Subjects have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma, which has come back or not gone away after treatment, including the best treatment we know for relapsed Lymphoma. We are asking subjects to volunteer to be in a research study using Epstein Barr virus (EBV) specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been used successfully in children with other types of blood cancer caused by EBV after bone marrow transplantation.
Some patients with Hodgkin disease or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis of Lymphoma. EBV is often found in the cancer cells suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are very clever because they are able to hide from the body's immune system and escape destruction. We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells and give them back to subjects.
Detailed description
We will take 60-70 ml (12 teaspoonfuls) of blood from the subject. We will first make a B cell line called a lymphoblastoid cell line or LCL by infecting the subjects blood with a laboratory strain of EBV called B95. We will then use use this EBV infected cell line (which have been treated with radiation so that they cannot grow) as stimulator cells and mix it with more blood. This stimulation will train the T cells to kill EBV infected cells and result in the growth of an EBV specific T cell line. We will then test the T cells to make sure that they kill the EBV infected cells and not your normal cells and freeze them.
The cells will be thawed and injected into subjects over 10 minutes, after pretreatment with Tylenol and Benadryl. A total of two doses will be given two weeks apart. All of the treatments will be given at Texas Children's Hospital or The Methodist Hospital.
We will follow subjects in the clinic after the injections. At each visit about 10ml (2 teaspoonfuls) of blood will be taken every other week for 6 weeks after the injection and then every 3 months for 1 year to monitor the subjects blood chemistry and hematology.
To learn more about the way the T cells are working in the subjects body, an extra 40mls (8 teaspoons) of blood will be taken pre-infusion, 3-4 days post infusion (optional) and at 1, 2, 4 and 6 weeks post-infusion and then at 3, 6, 9, and 12 months. The blood may be drawn from the subjects central line at the time of their regular blood tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTL Administration | Experimental | Drug: Infusion of EBV Specific Cytotoxic T-LymphocytesInfusion of EBV Specific Cytotoxic T-Lymphocytes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Any patient with Hodgkin disease or non-Hodgkin Lymphoma, containing the EBV genome or antigen, receiving an autologous bone marrow transplant regardless of age or sex.
- Patients with tumor tissue EBV +ve.
- Patients with life expectancy >6 weeks.
- Patients with Karnofsky score of > 50.
- No severe intercurrent infection.
Key exclusion criteria (10 listed)
- Patients with a life expectancy of <6 weeks.
- Patients with an EBV positive Lymphoma secondary to an acquired or congenital immunodeficiency.
- Patients with a Karnofsky score less than or equal to 50.
- Patients with a severe intercurrent infection.
- Patients with a bilirubin >2x normal,SGOT >3x normal, or abnormal prothrombin time.
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 |
|---|---|---|
| Infusion of EBV Specific Cytotoxic T-LymphocytesEBV specific cytotoxic T-lymphocytes will be given by intravenous injection over 1-10 minutes. Each patient will receive two injections, 14 days apart. | Drug | CTL Administration |
Primary outcome
determine the safety of 2 IV injections of autologously derived EBV specific cytotoxic T-lymphocytes
Time frame: 8 weeks
The two injections will be given at day 0 and day 14. Three patients will be enrolled at the first dose level and followed for six weeks after the second dose (which will constitute a course) for evaluation of any critical toxicity.
1 secondary outcome
determine the survival, immunological efficacy and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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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.
Catherine Bollard, MD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infusion of EBV Specific Cytotoxic T-Lymphocytes in people with Hodgkin Disease and Non-Hodgkins Lymphoma, run by Baylor College of Medicine at 2 sites 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 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
determine the safety of 2 IV injections of autologously derived EBV specific cytotoxic T-lymphocytes (time frame: 8 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 6 Nov 2012.