InfectionNCT00547235
Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection
A study testing therapeutic allogeneic lymphocytes, allogeneic bone marrow transplantation and total-body irradiation in people with Infection and Precancerous/Nonmalignant Condition, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Collecting the T cells from a donor and transplanting them into a patient may be effective treatment for immunodeficiency syndrome and CMV infection. PURPOSE: This clinical trial is studying the emergency use of adoptive immunotherapy with CMV-specific T cells after donor bone marrow transplant of an infant… Read more about this study
- Who is it for?
- Ages Up to 1 year, women only
- Conditions the study is for
- Infection, Precancerous/Nonmalignant Condition
- What is being tested?
- therapeutic allogeneic lymphocytes, allogeneic bone marrow transplantation and total-body irradiation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2012
- Phase
- Expanded access
- 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 Up to 1 year
- Women only
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Adenosine deaminase-deficient severe combined immunodeficiency syndrome (ADA-SCIDs)
- CMV interstitial pneumonia based on the constellation of clinical and radiological findings
PATIENT CHARACTERISTICS:
- Female
- Oxygen desaturation (pulse oximetry 85% on room air)
- Abnormal chest radiograph
- No CMV retinitis
PRIOR CONCURRENT THERAPY:
- Prior ganciclovir and foscarnet sodium
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109-1024
About this study
Official title: Protocol For The Emergency Use Of Adoptive Immunotherapy With CMV-Specific T Cells Following HLA-Matched Unrelated Donor Bone Marrow Transplant Of An Infant With ADA-SCIDs And Pre Transplant CMV Infection
RATIONALE: Collecting the T cells from a donor and transplanting them into a patient may be effective treatment for immunodeficiency syndrome and CMV infection.
PURPOSE: This clinical trial is studying the emergency use of adoptive immunotherapy with CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency syndrome and CMV infection.
Read the detailed description
OBJECTIVES:
- To determine if adoptive immunotherapy with donor-derived CD4+ and CD8+ CMV- specific cytotoxic lymphocyte cell lines can augment T-cell immunity and treat CMV infection post transplant in a patient with severe combined immunodeficiency syndrome.
OUTLINE: The patient will undergo HLA-matched unrelated donor bone marrow transplantation from a CMV-seropositive donor after undergoing conditioning with 200cGy total-body irradiation per protocol FHCRC Protocol 1227.
CD8-positive and CD4-positive CMV-specific T cells are collected from the donor and used to generate T-cell lines.
If the patient has progressive or persistent CMV infection, then she will receive donor T cells IV over 30 minutes. Infusions may be repeated after at least 14 days if the previous infusion was well tolerated and if the CMV infection is persistent or increasing.
The patient undergoes blood sample collection at baseline and 7 days after T-cell infusion to assess CMV-specific T-cell response.
- Conditions
- Infection, Precancerous/Nonmalignant Condition
- Being tested
- therapeutic allogeneic lymphocytes, allogeneic bone marrow transplantation, total-body irradiation
- Keywords
- infection, precancerous/nonmalignant condition
- Medical subject headings
- Infections, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic allogeneic lymphocytesBiological
allogeneic bone marrow transplantationProcedure or surgery
total-body irradiationRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Thomas Manley, MD, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547235
- Sponsor's protocol ID
- 2215.00
- Other IDs
- FHCRC-2215.00, CDR0000570998
- Status last verified
- Aug 2010
- First submitted
- 19 Oct 2007
- Last updated
- 24 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol For The Emergency Use Of Adoptive Immunotherapy With CMV-Specific T Cells Following HLA-Matched Unrelated Donor Bone Marrow Transplant Of An Infant With ADA-SCIDs And Pre Transplant CMV Infection
- ClinicalTrials.gov ID
- NCT00547235
- Acronym / sponsor ID
- 2215.00
- Conditions
- Infection, Precancerous/Nonmalignant Condition
- Keywords
- infection, precancerous/nonmalignant condition
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2007
- Primary completion
- Dec 2012 (estimated)
- First posted
- 22 Oct 2007 (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: Collecting the T cells from a donor and transplanting them into a patient may be effective treatment for immunodeficiency syndrome and CMV infection.
PURPOSE: This clinical trial is studying the emergency use of adoptive immunotherapy with CMV-specific T cells after donor bone marrow transplant of an infant with immunodeficiency syndrome and CMV infection.
Detailed description
OBJECTIVES:
- To determine if adoptive immunotherapy with donor-derived CD4+ and CD8+ CMV- specific cytotoxic lymphocyte cell lines can augment T-cell immunity and treat CMV infection post transplant in a patient with severe combined immunodeficiency syndrome.
OUTLINE: The patient will undergo HLA-matched unrelated donor bone marrow transplantation from a CMV-seropositive donor after undergoing conditioning with 200cGy total-body irradiation per protocol FHCRC Protocol 1227.
CD8-positive and CD4-positive CMV-specific T cells are collected from the donor and used to generate T-cell lines.
If the patient has progressive or persistent CMV infection, then she will receive donor T cells IV over 30 minutes. Infusions may be repeated after at least 14 days if the previous infusion was well tolerated and if the CMV infection is persistent or increasing.
The patient undergoes blood sample collection at baseline and 7 days after T-cell infusion to assess CMV-specific T-cell response.
Study design
Who may qualify
- Ages
- Up to 1 year
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| therapeutic allogeneic lymphocytes | Biological | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| total-body irradiation | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
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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.
Thomas Manley, MD principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic allogeneic lymphocytes, allogeneic bone marrow transplantation and total-body irradiation in people with Infection and Precancerous/Nonmalignant Condition, run by Fred Hutchinson Cancer 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 24 Aug 2010. 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?
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.
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 24 Aug 2010.