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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Nandita Khera, M.D., M.P.H.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20145583

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