CancerPhase 1NCT00769613
Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
A Phase 1 study testing cytomegalovirus IE-1-specific cytotoxic T lymphocytes, cytomegalovirus pp65-specific cytotoxic T lymphocytes and therapeutic allogeneic lymphocytes in people with Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus. PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- cytomegalovirus IE-1-specific cytotoxic T lymphocytes, cytomegalovirus pp65-specific cytotoxic T lymphocytes and therapeutic allogeneic lymphocytes
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2014
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Recipient of an allogeneic stem cell transplantation
- Cytomegalovirus (CMV)-seropositive and meeting 1 of the following criteria:
- Patient has a history of CMV antigenemia for ≥ 2 weeks
- CMV DNA levels ≥ 600 copies/mcg of DNA despite antiviral therapy targeting CMV (e.g., ganciclovir or foscarnet)
- No ongoing graft-vs-host disease
- Has donor available for peripheral blood mononuclear cell collection (for cytotoxic T lymphocytes production), meeting either of the following criteria:
- CMV-seropositive donor (≥ 2 years of age)
- CMV-seronegative related donor (≥ 18 years of age) who consents to receive the CMV vaccine
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-3 OR Lansky PS 50-100% (for patients < 16 years of age)
- Bilirubin < 2.0 mg/dL
- AST and ALT < 2.5 times normal
- Creatinine clearance ≥ 30 mL/min
- Pulse oximetry ≥ 94% on no more than 40% oxygen by face mask
- Not moribund
- No patients expected to survive ≤ 1 month after the T-cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Must be on ≤ 1 mg/kg/day of prednisone or its equivalent at the time of study CTL infusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
About this study
Official title: Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections
RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus.
PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.
Read the detailed description
OBJECTIVES:
Primary
- To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell transplantation.
Secondary
- To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter.
- To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL and observe whether the CTL infusion has any impact on level of virus.
- To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have received a CMV vaccine.
OUTLINE: This is a multicenter study.
Patients receive allogeneic cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T-cell lymphocytes infusion over 5 minutes on day 1. Patients may receive up to 2 more doses at least 2 weeks after previous dose.
Blood samples are collected and analyzed by quantitative CMV PCR, chromium-release assays for CMV pp65- and IE-1-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56, CD19, and CD45RA/RO. Intracellular cytofluorometry is used to assess IL-2, IL-4, IL-10, and IFN-γ production by CD4 and CD8 CMV-specific effector cells.
After completion of study therapy, patients are followed periodically for up to 1 year.
- Conditions
- Cancer
- Being tested
- cytomegalovirus IE-1-specific cytotoxic T lymphocytes, cytomegalovirus pp65-specific cytotoxic T lymphocytes, therapeutic allogeneic lymphocytes, polymerase chain reaction, flow cytometry
- Keywords
- stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma
- Medical subject headings
- Neoplasms, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytomegalovirus IE-1-specific cytotoxic T lymphocytesBiological
cytomegalovirus pp65-specific cytotoxic T lymphocytesBiological
therapeutic allogeneic lymphocytesBiological
polymerase chain reactionGenetic
flow cytometryOther
immunological diagnostic methodOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Toxicity
Secondary outcomes (4)
Time to development of cytomegalovirus (CMV)-specific immune reconstitution
CMV DNA levels
Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL)
Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Supportive care
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Kenneth G. Lucas, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769613
- Sponsor's protocol ID
- CDR0000615167
- Other IDs
- PSCI-PSHCI-08-051
- Status last verified
- Aug 2010
- First submitted
- 8 Oct 2008
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections
- ClinicalTrials.gov ID
- NCT00769613
- Acronym / sponsor ID
- CDR0000615167
- Conditions
- Cancer
- Keywords
- stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Aug 2014 (estimated)
- First posted
- 9 Oct 2008 (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: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus.
PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.
Detailed description
OBJECTIVES:
Primary
- To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell transplantation.
Secondary
- To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter.
- To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL and observe whether the CTL infusion has any impact on level of virus.
- To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have received a CMV vaccine.
OUTLINE: This is a multicenter study.
Patients receive allogeneic cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T-cell lymphocytes infusion over 5 minutes on day 1. Patients may receive up to 2 more doses at least 2 weeks after previous dose.
Blood samples are collected and analyzed by quantitative CMV PCR, chromium-release assays for CMV pp65- and IE-1-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56, CD19, and CD45RA/RO. Intracellular cytofluorometry is used to assess IL-2, IL-4, IL-10, and IFN-γ production by CD4 and CD8 CMV-specific effector cells.
After completion of study therapy, patients are followed periodically for up to 1 year.
Study design
- Primary purpose
- Supportive care
- Masking
- None (open label)
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| cytomegalovirus IE-1-specific cytotoxic T lymphocytes | Biological | – |
| cytomegalovirus pp65-specific cytotoxic T lymphocytes | Biological | – |
| therapeutic allogeneic lymphocytes | Biological | – |
| polymerase chain reaction | Genetic | – |
| flow cytometry | Other | – |
| immunological diagnostic method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Safety
Toxicity
4 secondary outcomes
Time to development of cytomegalovirus (CMV)-specific immune reconstitution
CMV DNA levels
Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL)
Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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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 principal investigator
Milton S. Hershey Medical Center
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 cytomegalovirus IE-1-specific cytotoxic T lymphocytes, cytomegalovirus pp65-specific cytotoxic T lymphocytes and therapeutic allogeneic lymphocytes in people with Cancer, run by Milton S. Hershey Medical Center 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?
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: status not confirmed, as of the sponsor's last update on 18 Dec 2013. 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?
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?
Safety. 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 18 Dec 2013.