Graft Versus Host Disease (GVHD)NCT01324908
Biomarkers in Predicting Response in Patients With Graft-Versus-Host Disease Undergoing Extracorporeal Photophoresis
A study testing extracorporeal photopheresis and laboratory biomarker analysis in people with Graft Versus Host Disease (GVHD), run by Vanderbilt-Ingram Cancer Center at 4 sites in United States.
Trial summary
This clinical trial studies biomarkers in predicting response in patients with graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats the patient's blood with ultraviolet light outside the body and kills the white blood cells before returning blood back into the patient's body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease (GVHD)
- What is being tested?
- extracorporeal photopheresis and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2011to 16 Nov 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with any NIH subtype of chronic GVHD that is being treated with ECP
- Karnofsky Performance Scale (KPS) > 60% at time of study enrollment
- Life expectancy > 3 months
- Steroid dose not greater than 2 mg/kg prednisone equivalent at time of study enrollment
- If patient has steroid refractory GVHD (defined as worsening of GVHD after 3 days of 2 mg/kg prednisone equivalent or no improvement after 7 days of 2 mg/kg prednisone equivalent), time interval from start of steroids to initiation of ECP should not be > 14 days
- No use of an investigational agent within 2 weeks of starting ECP
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- No uncontrolled bacterial, fungal or viral disease (therapy for cytomegalovirus [CMV] viremia is permitted)
- No evidence of relapse or progression of underlying disease (molecular evidence of relapse/progression or mixed chimerism is permitted)
- Women of childbearing potential (WOCBP) should be willing to use 2 forms of contraception; male patients should be willing to use contraception
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Who cannot join
- Female patients who are breastfeeding or pregnant
- Patients known to be human immunodeficiency virus (HIV) positive
- Bronchiolitis obliterans as the sole indication of ECP
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Mechanical ventilation, renal replacement therapy, admitted in intensive care until at time of enrollment
- Stage 4 gastrointestinal GVHD as per Seattle-Glucksberg criteria
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30322
Dana Farber Cancer Center
Boston, Massachusetts, 02114
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Virginia Commonwealth University, Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis
This clinical trial studies biomarkers in predicting response in patients with graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats the patient's blood with ultraviolet light outside the body and kills the white blood cells before returning blood back into the patient's body. Studying samples of blood from patients with GVHD may help doctors identify and learn more about biomarkers related to GVHD.
Read the detailed description
PRIMARY OBJECTIVE:
- To show that extracorporeal photopheresis (ECP)increases skin and gut homing T regulatory (T-reg) cells in patients with GVHD clinically responding to ECP.
SECONDARY OBJECTIVES:
- Response rates of GVHD with extracorporeal photopheresis(ECP)as measured by NIH response criteria
II. Incidence of T-reg cell frequency(%)with various NIH subtypes of chronic graft-versus-host disease (GVHD)
III. Incidence of T-reg homing subsets(%)with various NIH subtypes of chronic graft-versus-host disease (GVHD)
OUTLINE:
Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks.
After completion of study treatment, patients are followed up at 2, 4, and 6 months.
- Conditions
- Graft Versus Host Disease (GVHD)
- Being tested
- extracorporeal photopheresis, laboratory biomarker analysis
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal photopheresisProcedure or surgery
Also called extracorporeal photophoresis
Undergo ECP
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Treg predictor of response to ECP) | Experimental | Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks. Receives: Procedure: extracorporeal photopheresis; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP.
Measured: 6 months after last patient is on study
Secondary outcomes (3)
Response rates of GVHD with ECP as measured by NIH response criteria
Measured: at 6 months
Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD
Measured: at 6 months
Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJul 2011
- Primary completion28 Jul 2017
- Study completion16 Nov 2020
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host Disease (GVHD)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michael Byrne, Vanderbilt-Ingram Cancer Center
- Investigators
- Madan Jagasia, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324908
- Sponsor's protocol ID
- VICC CTT 1063
- Other IDs
- NCI-2011-00225
- Status last verified
- Jan 2021
- First submitted
- 7 Mar 2011
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-regulatory Homing Subsets as a Predictor of Response in GVHD Treated With Extracorporeal Photopheresis
- ClinicalTrials.gov ID
- NCT01324908
- Acronym / sponsor ID
- VICC CTT 1063
- Conditions
- Graft Versus Host Disease (GVHD)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2011
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 29 Mar 2011 (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 clinical trial studies biomarkers in predicting response in patients with graft-versus-host disease (GVHD) undergoing extracorporeal photopheresis (ECP). ECP treats the patient's blood with ultraviolet light outside the body and kills the white blood cells before returning blood back into the patient's body. Studying samples of blood from patients with GVHD may help doctors identify and learn more about biomarkers related to GVHD.
Detailed description
PRIMARY OBJECTIVE:
- To show that extracorporeal photopheresis (ECP)increases skin and gut homing T regulatory (T-reg) cells in patients with GVHD clinically responding to ECP.
SECONDARY OBJECTIVES:
- Response rates of GVHD with extracorporeal photopheresis(ECP)as measured by NIH response criteria
II. Incidence of T-reg cell frequency(%)with various NIH subtypes of chronic graft-versus-host disease (GVHD)
III. Incidence of T-reg homing subsets(%)with various NIH subtypes of chronic graft-versus-host disease (GVHD)
OUTLINE:
Patients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks.
After completion of study treatment, patients are followed up at 2, 4, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Treg predictor of response to ECP) | Experimental | Procedure: extracorporeal photopheresis, Other: laboratory biomarker analysisPatients undergo ECP twice a week for 4 weeks and then twice a week every 2 weeks for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with any NIH subtype of chronic GVHD that is being treated with ECP
- Karnofsky Performance Scale (KPS) > 60% at time of study enrollment
- Life expectancy > 3 months
- Steroid dose not greater than 2 mg/kg prednisone equivalent at time of study enrollment
- If patient has steroid refractory GVHD (defined as worsening of GVHD after 3 days of 2 mg/kg prednisone equivalent or no improvement after 7 days of 2 mg/kg prednisone equivalent), time interval from start of steroids to initiation of ECP should not be > 14 days
Key exclusion criteria (6 listed)
- Female patients who are breastfeeding or pregnant
- Patients known to be human immunodeficiency virus (HIV) positive
- Bronchiolitis obliterans as the sole indication of ECP
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Mechanical ventilation, renal replacement therapy, admitted in intensive care until at time of enrollment
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 |
|---|---|---|
| extracorporeal photopheresisAlso: extracorporeal photophoresisUndergo ECP | Procedure or surgery | Treatment (Treg predictor of response to ECP) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (Treg predictor of response to ECP) |
Primary outcome
Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP.
Time frame: 6 months after last patient is on study
3 secondary outcomes
Response rates of GVHD with ECP as measured by NIH response criteria
Time frame: at 6 months
Incidence of T-reg cell frequency (%) with various NIH subtypes of chronic GVHD
Time frame: at 6 months
Incidence of T-reg homing subsets (%) with various NIH subtypes of chronic GVHD
Time frame: at 6 months
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink 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.
Madan Jagasia principal investigator
Vanderbilt-Ingram Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extracorporeal photopheresis and laboratory biomarker analysis in people with Graft Versus Host Disease (GVHD), run by Vanderbilt-Ingram Cancer Center at 4 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 10 inclusion and 6 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study was stopped early (reason given: Low accrual). 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?
Association of frequency of skin and gut homing Tregs (%) in patients with chronic GVHD with response to ECP. (time frame: 6 months after last patient is on study). 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 14 Jan 2021.