Graft Versus Host DiseasePOSTAGENCT02151539
Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)
An observational study of Graft Versus Host Disease, run by Vanderbilt-Ingram Cancer Center at 7 sites in 4 countries.
Trial summary
This research trial studies medical chart review in determining outcomes of second-line therapy in patients with acute graft-versus-host disease previously treated with extracorporeal photopheresis or other systemic therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- medical chart review and quality-of-life assessment
- How many people
- 19 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 29 Aug 2014to 11 Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study targets patients with acute graft-versus-host disease previously treated with extracorporeal photopheresis or other systemic therapies. Patients can be enrolled by all participating locations.
Who may be able to join
- Enrollment on study is within 5 days (including weekends) of starting second-line therapy
- aGVHD grade 2 or higher at time of enrollment; patients with late acute and recurrent aGVHD are permitted
- Donor lymphocyte induced aGVHD is permitted ONLY IF donor lymphocyte infusion given for mixed chimerism and not for progression of disease and meeting all other inclusion and exclusion criteria will be eligible
- Corticosteroid refractory or corticosteroid dependent aGVHD
- Corticosteroid refractory aGVHD is defined as worsening of aGVHD after 3 days of systemic corticosteroids (minimum dose of 1 mg/kg), or no improvement after 7 days of systemic corticosteroids (minimum dose of 1 mg/kg)
- Corticosteroid dependent aGVHD is defined as recurrence of aGVHD (grade 2 or higher) during corticosteroid taper and prior to reaching 50% of initial starting dose of corticosteroids
- Informed consent form
Who cannot join
- Has received corticosteroids at 2 mg/kg or higher for 3 weeks or longer as part of first-line therapy for aGVHD
- Has received systemic therapy other than corticosteroids for treatment of aGVHD as part of first-line therapy for acute GVHD; simultaneous uses of topical or enteric corticosteroids or psoralen plus ultraviolet A (PUVA) for first-line are permitted
- aGVHD after second hematopoietic cell transplantation (HCT) is excluded
- Karnofsky performance status =< 50%
- Requiring mechanical ventilation or renal replacement therapy at the time of enrollment
- Histologic or flow-cytometric evidence of relapse or progression of underlying disease; molecular or cytogenetic presence of disease is permitted; mixed chimerism is permitted
- Current or prior diagnosis of chronic GVHD (classic or overlap) as defined by National Institutes of Health (NIH) consensus criteria
- Donor lymphocyte infusion (DLI)-induced aGVHD when DLI was given for progression of the underlying disease
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States4 sites
The Cleveland Clinic
Cleveland, Ohio, 44195
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, 37232
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
This research trial studies medical chart review in determining outcomes of second-line therapy in patients with acute graft-versus-host disease previously treated with extracorporeal photopheresis or other systemic therapies. Gathering information about second-line therapy in patients with acute graft-versus-host disease may help doctors learn more about the disease and find better treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine 6-month freedom from treatment failure for second-line therapy for acute graft versus host disease (aGVHD).
II. To show that extracorporeal photopheresis (ECP) is associated with a superior 6 month (m) freedom from treatment failure (FFTF) as compared to other treatment modalities for second line therapy for aGVHD.
III. To describe health care burden in patients receiving second line therapy for acute GVHD.
IV. Quality of life measurement using Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) in patients receiving second line therapy for aGVHD.
OUTLINE:
Study data are collected and managed using Research Electronic Data Capture (REDCap) tools at baseline and on days 5, 28, and 56.
After completion of study, patients are followed up at 6 months, and 1 and 2 years.
- Conditions
- Graft Versus Host Disease
- Being tested
- medical chart review, quality-of-life assessment
- 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.
medical chart reviewOther
Also called chart review
Ancillary studies
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (medical chart review) | Study data are collected and managed using REDCap tools at baseline and on days 5, 28, and 56. Receives: Other: medical chart review; Other: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month freedom from treatment failure, defined as a patient being alive, without relapse of underlying disease, and without the addition of new systemic therapy for the treatment of aGVHD, within 6 months of starting second line therapy
Rates of 6 m FFTF will be estimated by subtracting rates of total failures from 100%.
Measured: 6 months
Cumulative incidence estimates of relapse
Cox regression models will be used to identify risk factors for failure.
Measured: Up to 2 years
Cumulative incidence estimates of non-relapse mortality
Cox regression models will be used to identify risk factors for failure.
Measured: Up to 2 years
Treatment change as causes of failure during second line treatment
Cox regression models will be used to identify risk factors for failure.
Measured: Up to 2 years
Health care burden in patients receiving second line therapy for acute GVHD
The incremental budget spend between the patients receiving treatment with ECP and patients receiving other modalities will be measured and economic methods will be used to calculate an incremental cost effectiveness ratio for relevant clinical end points. Health economic data relating to hospitalizations (length of stay in myelosuppressive unit, high-dependency unit [step-down unit], intensive care unit), high cost drugs, total parenteral nutrition and surgical procedures will also be collected allowing comparisons to be made between patients treated with ECP and other treatment options.
Measured: Up to 6 months
Quality of life measured using FACT-BMT
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study start29 Aug 2014
- Primary completion11 Oct 2018
- Study completion11 Oct 2018
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 DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 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, Madan Jagasia, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Madan Jagasia, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151539
- Sponsor's protocol ID
- VICC BMT 1401
- Other IDs
- NCI-2014-01026, VICC BMT 1401, P30CA068485
- Acronym
- POSTAGE
- Status last verified
- Oct 2019
- First submitted
- 28 May 2014
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)
- ClinicalTrials.gov ID
- NCT02151539
- Acronym / sponsor ID
- POSTAGE / VICC BMT 1401
- Conditions
- Graft Versus Host Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Aug 2014 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 30 May 2014 (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 medical chart review in determining outcomes of second-line therapy in patients with acute graft-versus-host disease previously treated with extracorporeal photopheresis or other systemic therapies. Gathering information about second-line therapy in patients with acute graft-versus-host disease may help doctors learn more about the disease and find better treatment.
Detailed description
PRIMARY OBJECTIVES:
- To determine 6-month freedom from treatment failure for second-line therapy for acute graft versus host disease (aGVHD).
II. To show that extracorporeal photopheresis (ECP) is associated with a superior 6 month (m) freedom from treatment failure (FFTF) as compared to other treatment modalities for second line therapy for aGVHD.
III. To describe health care burden in patients receiving second line therapy for acute GVHD.
IV. Quality of life measurement using Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) in patients receiving second line therapy for aGVHD.
OUTLINE:
Study data are collected and managed using Research Electronic Data Capture (REDCap) tools at baseline and on days 5, 28, and 56.
After completion of study, patients are followed up at 6 months, and 1 and 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (medical chart review) | – | Other: medical chart review, Other: quality-of-life assessmentStudy data are collected and managed using REDCap tools at baseline and on days 5, 28, and 56. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study targets patients with acute graft-versus-host disease previously treated with extracorporeal photopheresis or other systemic therapies. Patients can be enrolled by all participating locations.
Key inclusion criteria (7 listed)
- Enrollment on study is within 5 days (including weekends) of starting second-line therapy
- aGVHD grade 2 or higher at time of enrollment; patients with late acute and recurrent aGVHD are permitted
- Donor lymphocyte induced aGVHD is permitted ONLY IF donor lymphocyte infusion given for mixed chimerism and not for progression of disease and meeting all other inclusion and exclusion criteria will be eligible
- Corticosteroid refractory or corticosteroid dependent aGVHD
- Informed consent form
Key exclusion criteria (8 listed)
- Has received corticosteroids at 2 mg/kg or higher for 3 weeks or longer as part of first-line therapy for aGVHD
- Has received systemic therapy other than corticosteroids for treatment of aGVHD as part of first-line therapy for acute GVHD; simultaneous uses of topical or enteric corticosteroids or psoralen plus ultraviolet A (PUVA) for first-line are permitted
- aGVHD after second hematopoietic cell transplantation (HCT) is excluded
- Karnofsky performance status =< 50%
- Requiring mechanical ventilation or renal replacement therapy at the 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 |
|---|---|---|
| medical chart reviewAlso: chart reviewAncillary studies | Other | Observational (medical chart review) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Observational (medical chart review) |
Primary outcome
6-month freedom from treatment failure, defined as a patient being alive, without relapse of underlying disease, and without the addition of new systemic therapy for the treatment of aGVHD, within 6 months of starting second line therapy
Time frame: 6 months
Rates of 6 m FFTF will be estimated by subtracting rates of total failures from 100%.
Cumulative incidence estimates of relapse
Time frame: Up to 2 years
Cox regression models will be used to identify risk factors for failure.
Cumulative incidence estimates of non-relapse mortality
Time frame: Up to 2 years
Cox regression models will be used to identify risk factors for failure.
Treatment change as causes of failure during second line treatment
Time frame: Up to 2 years
Cox regression models will be used to identify risk factors for failure.
Health care burden in patients receiving second line therapy for acute GVHD
Time frame: Up to 6 months
The incremental budget spend between the patients receiving treatment with ECP and patients receiving other modalities will be measured and economic methods will be used to calculate an incremental cost effectiveness ratio for relevant clinical end points. Health economic data relating to hospitalizations (length of stay in myelosuppressive unit, high-dependency unit [step-down unit], intensive care unit), high cost drugs, total parenteral nutrition and surgical procedures will also be collected allowing comparisons to be made between patients treated with ECP and other treatment options.
Quality of life measured using FACT-BMT
Time frame: Up to 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 17 Oct 2019.
- 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
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Versus Host Disease, run by Vanderbilt-Ingram Cancer Center at 7 sites in 4 countries.
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 7 inclusion and 8 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 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Austria, Germany, United Kingdom. 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?
6-month freedom from treatment failure, defined as a patient being alive, without relapse of underlying disease, and without the addition of new systemic therapy for the treatment of aGVHD, within 6 months of starting second line therapy (time frame: 6 months). The study lists 6 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 17 Oct 2019.