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

NCT02151539 | Terminated DMC

• 3 other identifiers: VICC BMT 1401NCI-2014-01026P30CA068485
• Study Type: observational
• Target: 19
• Locations: 4 countries
• Sites: 7

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.

Conditions

Graft Versus Host Disease

Outcome Measures

Primary Outcomes (6)

• 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

• Cumulative incidence estimates of relapse

  Cox regression models will be used to identify risk factors for failure.

  Up to 2 years

• Cumulative incidence estimates of non-relapse mortality

  Cox regression models will be used to identify risk factors for failure.

  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.

  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.

  Up to 6 months

• Quality of life measured using FACT-BMT

  Up to 6 months

Study Arms (1)

Observational (medical chart review)

Study data are collected and managed using REDCap tools at baseline and on days 5, 28, and 56.

Other: medical chart review; Other: quality-of-life assessment

Interventions

medical chart review OTHER

Ancillary studies

Also known as: chart review

Observational (medical chart review)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Observational (medical chart review)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt-Ingram Cancer Center (VICC)

Nashville, Tennessee, 37232, United States

Location

Medical University Vienna

Vienna, A-1090, Austria

Location

Klinikum der Universität Regensburg

Regensburg, 93053, Germany

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Madan Jagasia

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: August 29, 2014
• Primary Completion: October 11, 2018
• Study Completion: October 11, 2018
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

GB (1); AU (1); DE (1); US (4)