Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)

Graft Versus Host Disease Clinical Trial

— POSTAGE  

Official title:

Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02151539
• Other study ID #: VICC BMT 1401
• Secondary ID: NCI-2014-01026VI
• Status: Terminated
• Start date: August 29, 2014
• Est. completion date: October 11, 2018

Study information

• Verified date: October 2019
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 11, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Other:
• medical chart review
Ancillary studies
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna
Germany	Klinikum der Universität Regensburg	Regensburg
United Kingdom	Nottingham City Hospital	Nottingham
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Vanderbilt-Ingram Cancer Center (VICC)	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Austria,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	6 months
Primary	Cumulative incidence estimates of relapse	Cox regression models will be used to identify risk factors for failure.	Up to 2 years
Primary	Cumulative incidence estimates of non-relapse mortality	Cox regression models will be used to identify risk factors for failure.	Up to 2 years
Primary	Treatment change as causes of failure during second line treatment	Cox regression models will be used to identify risk factors for failure.	Up to 2 years
Primary	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.	Up to 6 months
Primary	Quality of life measured using FACT-BMT		Up to 6 months

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial