Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)
NCT ID: NCT02151539
Last Updated: 2019-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
19 participants
OBSERVATIONAL
2014-08-29
2018-10-11
Brief Summary
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Detailed Description
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I. 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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Observational (medical chart review)
Study data are collected and managed using REDCap tools at baseline and on days 5, 28, and 56.
medical chart review
Ancillary studies
quality-of-life assessment
Ancillary studies
Interventions
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medical chart review
Ancillary studies
quality-of-life assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aGVHD grade 2 or higher at time of enrollment; patients with late acute and recurrent aGVHD are permitted
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Madan Jagasia, MD
Principal Investigator
Principal Investigators
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Madan Jagasia
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic
Rochester, Minnesota, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, United States
Medical University Vienna
Vienna, , Austria
Klinikum der Universität Regensburg
Regensburg, , Germany
Nottingham City Hospital
Nottingham, , United Kingdom
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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NCI-2014-01026
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC BMT 1401
Identifier Type: OTHER
Identifier Source: secondary_id
VICC BMT 1401
Identifier Type: -
Identifier Source: org_study_id
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