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

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Medical Conditions
  • Graft Versus Host Disease
Primary Contact Details
Vanderbilt Cancer Center Clinical Trial Information Program
800-811-8480
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02151539
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • 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.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Observational
Intervention
Other : medical chart review, Other : quality-of-life assessment

Study Arm Groups : Observational (medical chart review), Observational (medical chart review)

Intervention Type
See Interventions above
Primary Outcome Measures
    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; 6 months; Cumulative incidence estimates of relapse; Up to 2 years; Cumulative incidence estimates of non-relapse mortality; Up to 2 years; Treatment change as causes of failure during second line treatment; Up to 2 years; Health care burden in patients receiving second line therapy for acute GVHD; Up to 6 months; Quality of life measured using FACT-BMT; Up to 6 months
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
105
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Nottingham
Nottinghamshire
NG5 1PB
Trial Contact(s)
Primary Trial Contact
Vanderbilt Cancer Center Clinical Trial Information Program
800-811-8480
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Austria, Germany, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Prospective Outcomes of Second-Line Therapy in Acute Graft-Versus-Host Study Including ECP (POSTAGE)
EudraCT Number
Not available for this trial
Funder(s)
  • National Cancer Institute (NCI)
Other Study ID Numbers
VICC BMT 1401
Sponsor(s)
Vanderbilt-Ingram Cancer Center
Key Dates

Recruitment Start Date

Aug 2014

Recruitment End Date

Jun 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

28 May 2014

Date updated in source

11 Aug 2017