Clinical trial NCT02151539: Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)
Official title: Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Graft Versus Host Disease
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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
timeFrame: 6 months
measure: Cumulative incidence estimates of relapse
timeFrame: Up to 2 years
measure: Cumulative incidence estimates of non-relapse mortality
timeFrame: Up to 2 years
measure: Treatment change as causes of failure during second line treatment
timeFrame: Up to 2 years
measure: Health care burden in patients receiving second line therapy for acute GVHD
timeFrame: Up to 6 months
measure: Quality of life measured using FACT-BMT
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center (VICC)
state: Tennessee
city: Vienna
country: Austria
facility: Medical University Vienna
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Madan Jagasia
role: PRINCIPAL_INVESTIGATOR
References: