LeukemiaPhase 1NCT00002956
Immunotherapy for Lymphoproliferative Diseases Associated With Epstein-Barr Virus in Patients Who Have Undergone Organ Transplants
A Phase 1 study testing allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes in people with Leukemia and Lymphoma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus. PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1996to Feb 2002
- 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
- Radiographic evidence of lymphadenopathy or lymphomatous lesions combined with clinical signs of Epstein-Barr virus lymphoproliferative disease (EBV LPD), such as fevers and lymphadenopathy
- following an organ transplant Persistent, progressive, or unresponsive disease despite decreased immunosuppression, chemotherapy, or radiation therapy EBV LPD must be of host origin
- At least 4 weeks
- Patients serologically hepatitis B and C positive may receive cytotoxic
- T- lymphocytes (CTL) from donors who are serologically positive for the same virus
- Must have an HLA identical or HLA haploidentical donor
Who cannot join
- hepatic dysfunction SGOT/SGPT less than 2.5 times upper limit of normal (unless liver metastases present)
- Bilirubin less than 2.0 mg/dL
- renal dysfunction
- Creatinine clearance at greater than 50 mL/min
- cardiac dysfunction
- neurologic dysfunction
Show all 10Show fewer
- pulmonary dysfunction
- patients developing EBV LPD who have a donor origin lymphoma
- HIV-1 positive
- Not capable of undergoing leukapheresis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
About this study
Official title: A Phase I Pilot Trial to Evaluate the Toxicity of Allogeneic Epstein-Barr Virus Specific T-Lymphocytes for the Treatment of EBV-Associated Lymphoproliferative Diseases in Organ Transplant Recipients
RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus.
PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus.
Read the detailed description
OBJECTIVES: I. Examine the toxic effects of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients. II. Determine the level of in vivo expansion of allogeneic CTL and the period of time during which these CTL's can be detected in the blood of recipients of the T cell infusions.
OUTLINE: Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression.
PROJECTED ACCRUAL: 10 patients will be accrued in this study.
- Being tested
- allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes
- Keywords
- recurrent adult Hodgkin lymphoma, recurrent childhood lymphoblastic lymphoma, childhood diffuse large cell lymphoma, childhood immunoblastic large cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, T-cell large granular lymphocyte leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse, Recurrence, Leukemia, Large Granular Lymphocytic, Lymphoma, Follicular, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytesBiological
| Study group | Role | What they receive |
|---|---|---|
| infusions of EBV specific cytotoxic T lymphocytes | Experimental | Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression Receives: Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events associated with administration of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients
Measured: baseline to x weeks post infusion
Mean length of time of allogeneic CTL during which these CTL's can be detected in the blood of recipients of the T cell infusions.
Measured: baseline to x weeks past infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2004 (estimated)
- Study startNov 1996
- Primary completionFeb 2002
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth G. Lucas, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002956
- Sponsor's protocol ID
- CDR0000065433
- Other IDs
- UAB-9739, IUMC-9611-37, NCI-V97-1176
- Status last verified
- Nov 2012
- First submitted
- 1 Nov 1999
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pilot Trial to Evaluate the Toxicity of Allogeneic Epstein-Barr Virus Specific T-Lymphocytes for the Treatment of EBV-Associated Lymphoproliferative Diseases in Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT00002956
- Acronym / sponsor ID
- CDR0000065433
- Keywords
- recurrent adult Hodgkin lymphoma, recurrent childhood lymphoblastic lymphoma, childhood diffuse large cell lymphoma, childhood immunoblastic large cell lymphoma, recurrent/refractory childhood Hodgkin lymphoma, T-cell large granular lymphocyte leukemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 1996
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 19 Jul 2004 (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.
RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus.
PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus.
Detailed description
OBJECTIVES: I. Examine the toxic effects of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients. II. Determine the level of in vivo expansion of allogeneic CTL and the period of time during which these CTL's can be detected in the blood of recipients of the T cell infusions.
OUTLINE: Donors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression.
PROJECTED ACCRUAL: 10 patients will be accrued in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infusions of EBV specific cytotoxic T lymphocytes | Experimental | Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytesDonors undergo leukapheresis, and Epstein-Barr virus (EBV) specific cytoxic T lymphocytes are cultivated in vitro. Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0, 2, and 4. Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Radiographic evidence of lymphadenopathy or lymphomatous lesions combined with clinical signs of Epstein-Barr virus lymphoproliferative disease (EBV LPD), such as fevers and lymphadenopathy
- following an organ transplant Persistent, progressive, or unresponsive disease despite decreased immunosuppression, chemotherapy, or radiation therapy EBV LPD must be of host origin
- At least 4 weeks
- Patients serologically hepatitis B and C positive may receive cytotoxic
- T- lymphocytes (CTL) from donors who are serologically positive for the same virus
Key exclusion criteria (10 listed)
- hepatic dysfunction SGOT/SGPT less than 2.5 times upper limit of normal (unless liver metastases present)
- Bilirubin less than 2.0 mg/dL
- renal dysfunction
- Creatinine clearance at greater than 50 mL/min
- cardiac dysfunction
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 |
|---|---|---|
| allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes | Biological | infusions of EBV specific cytotoxic T lymphocytes |
Primary outcome
Number of adverse events associated with administration of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients
Time frame: baseline to x weeks post infusion
Mean length of time of allogeneic CTL during which these CTL's can be detected in the blood of recipients of the T cell infusions.
Time frame: baseline to x weeks past infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
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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.
Kenneth G. Lucas, MD study chair
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes in people with Leukemia and Lymphoma, run by University of Alabama at Birmingham 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 6 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: withdrawn, as of the sponsor's last update on 21 Mar 2016. 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.
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 withdrawn before enrolling participants, so there are no results.
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?
Number of adverse events associated with administration of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients (time frame: baseline to x weeks post infusion). The study lists 2 primary outcomes in all. 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 21 Mar 2016.