Graft Versus Host DiseaseNCT01988701
Lymphocyte Profiles and Activation Status in Patients With Graft-Versus-Host Disease
An observational study of Graft Versus Host Disease and Hematopoietic/Lymphoid Cancer, run by Ohio State University Comprehensive Cancer Center.
Trial summary
This research trial studies lymphocyte profiles and activation status in patients with graft-versus-host disease. Studying samples of blood in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to graft-versus-host disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graft Versus Host Disease, Hematopoietic/Lymphoid Cancer
- What is being tested?
- Ancillary-Correlative
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2016
- Phase
- Observational
- 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
Study population: Patients who have received an autologous stem cell transplant and stem cell transplant at The Ohio State University.
Who may be able to join
- Allogeneic SCT groups: Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic graft-versus-host disease (GVHD)
- Autologous SCT group: Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment
Who cannot join
None listed.
About this study
Official title: Lymphocyte Profiles and Activation Status in the Development of Chronic Graft-versus-Host Disease
This research trial studies lymphocyte profiles and activation status in patients with graft-versus-host disease. Studying samples of blood in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to graft-versus-host disease.
Read the detailed description
PRIMARY OBJECTIVES:
- To explore and assess changes in subsets and activation status of B-, T,-, and natural killer (NK) lymphocytes in peripheral blood following allogeneic stem cell transplant and how they may be associated with clinical events with an ultimate future goal of conducting a larger successor study to identify potential therapeutic targets based on its findings.
SECONDARY OBJECTIVES:
- To assess the feasibility of obtaining and comparing patients with chronic graft-versus-host disease (cGVHD) with time-matched stem cell transplant (SCT) patients without cGVHD and identify logistical challenges with obtaining and processing samples in each of the subgroups of interest for these analyses.
II. To assess and explore differences in lymphocyte subsets (B-, T-, and NK) between those with vs. without cGVHD.
III. To assess and explore differences in cytokines in patients with cGVHD vs. those without.
IV. To describe lymphocyte subsets and activation and explore how these may be related to specific clinical manifestations of cGVHD.
OUTLINE:
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunosorbent spot (ELISPOT), immunoblot, and microarray assays.
- Being tested
- Ancillary-Correlative
- Keywords
- GVHD, chronic Graft versus Host Disease
- Medical subject headings
- Graft vs Host Disease, Hematologic Neoplasms, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ancillary-CorrelativeOther
Also called Correlatives studies, laboratory biomarker analysis
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic SCT Groups | Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic GVHD. Receives: Other: Ancillary-Correlative | |
| Autologous SCT group | Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment. Receives: Other: Ancillary-Correlative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subsets and activation status of B, T, and NK lymphocytes
Side by side box plots with overlaid plotted points will be used to assess potential differences in continuous markers between groups.
Measured: Up to 2 months
Secondary outcomes (4)
Logistical challenges with obtaining and processing samples in each of the subgroups of interest
Measured: Up to 2 months
Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD
Measured: Up to 2 months
Differences in cytokines in patients with cGVHD vs. those without
Measured: Up to 2 months
Differences in in lymphocyte activation between those with vs. without cGVHD
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startFeb 2015
- Primary completionDec 2016 (estimated)
Why it stopped: Decision made by the PI to withdraw study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Jaglowski, Ohio State University Comprehensive Cancer Center
- Investigators
- Samantha Jaglowski, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988701
- Sponsor's protocol ID
- OSU-12208
- Other IDs
- NCI-2013-01641
- Status last verified
- Feb 2015
- First submitted
- 14 Nov 2013
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphocyte Profiles and Activation Status in the Development of Chronic Graft-versus-Host Disease
- ClinicalTrials.gov ID
- NCT01988701
- Acronym / sponsor ID
- OSU-12208
- Keywords
- GVHD, chronic Graft versus Host Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Decision made by the PI to withdraw study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 20 Nov 2013 (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 trial studies lymphocyte profiles and activation status in patients with graft-versus-host disease. Studying samples of blood in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to graft-versus-host disease.
Detailed description
PRIMARY OBJECTIVES:
- To explore and assess changes in subsets and activation status of B-, T,-, and natural killer (NK) lymphocytes in peripheral blood following allogeneic stem cell transplant and how they may be associated with clinical events with an ultimate future goal of conducting a larger successor study to identify potential therapeutic targets based on its findings.
SECONDARY OBJECTIVES:
- To assess the feasibility of obtaining and comparing patients with chronic graft-versus-host disease (cGVHD) with time-matched stem cell transplant (SCT) patients without cGVHD and identify logistical challenges with obtaining and processing samples in each of the subgroups of interest for these analyses.
II. To assess and explore differences in lymphocyte subsets (B-, T-, and NK) between those with vs. without cGVHD.
III. To assess and explore differences in cytokines in patients with cGVHD vs. those without.
IV. To describe lymphocyte subsets and activation and explore how these may be related to specific clinical manifestations of cGVHD.
OUTLINE:
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunosorbent spot (ELISPOT), immunoblot, and microarray assays.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic SCT Groups | – | Other: Ancillary-CorrelativePatients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic GVHD. |
| Autologous SCT group | – | Other: Ancillary-CorrelativePatients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have received an autologous stem cell transplant and stem cell transplant at The Ohio State University.
Key inclusion criteria (2 listed)
- Allogeneic SCT groups: Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic graft-versus-host disease (GVHD)
- Autologous SCT group: Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ancillary-CorrelativeAlso: Correlatives studies, laboratory biomarker analysisBlood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays. | Other | Allogeneic SCT Groups, Autologous SCT group |
Primary outcome
Subsets and activation status of B, T, and NK lymphocytes
Time frame: Up to 2 months
Side by side box plots with overlaid plotted points will be used to assess potential differences in continuous markers between groups.
4 secondary outcomes
Logistical challenges with obtaining and processing samples in each of the subgroups of interest
Time frame: Up to 2 months
Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD
Time frame: Up to 2 months
Differences in cytokines in patients with cGVHD vs. those without
Time frame: Up to 2 months
Differences in in lymphocyte activation between those with vs. without cGVHD
Time frame: Up to 2 months
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 2 Mar 2015.
- The JameslineLink provided by the sponsor.
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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.
Samantha Jaglowski, MD principal investigator
Ohio State University Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Versus Host Disease and Hematopoietic/Lymphoid Cancer, run by Ohio State University Comprehensive Cancer Center.
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 2 inclusion and 0 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 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Subsets and activation status of B, T, and NK lymphocytes (time frame: Up to 2 months). 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 2 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.