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Graft Versus Host Disease

Chronic Graft-versus-Host Disease Treatment (FHCRC-2375)
A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus plus Prednisone, Sirolimus/Extracorporeal Photopheresis plus Prednisone, and Sirolimus/Calcineurin Inhibitor plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease (BMT CTN 0801)
Status Conditions Phase Study ID
Recruiting Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT) Phase II/III FHCRC-2375
NCT01106833
Summary

Purpose: This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone, sirolimus/extracorporeal photopheresis plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to one of the two pre-specified experimental arms (Sirolimus + prednisone, Sirolimus + ECP + prednisone) or the comparator arm (Sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.


Investigator
Paul Carpenter, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Suitable candidates are patients with chronic GVHD that is: a)High-risk (Platelets less than 100,000, greater than 50% skin involvement, bronchiolitis obliterans, or already being treated with prednisone greater than 0.5 mg/kg/day for a history of acute GVHD), newly diagnosed or not responding after up to 12 weeks of therapy with prednisone ± CNI ± an additional agent; b)Standard-risk and deemed inadequately responding after up to 12 weeks of therapy that began with prednisone at 0.5-1 mg/kg/day ± CNI; c) Inadequately responding to therapy with prednisone or sirolimus alone, or prednisone and ECP alone.
  • Classic chronic GVHD with or without overlap syndrome but not late persistent or recurrent acute GVHD alone, diagnosed according to the NIH Consensus Working Group Guidelines and which requires treatment with systemic immunosuppressive medication.
  • Weight more than or equal to 25 kg
  • Patient or guardian willing and able to provide informed consent.
  • Stated willingness to use contraception in women of childbearing potential.
  • Stated willingness of patient to comply with study procedures and reporting requirements.

Exclusion Criteria:

  • Inability to begin prednisone therapy at a dose of greater than 0.5 mg/kg/day.
  • Already receiving therapy with prednisone, sirolimus and CNI.
  • Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies.
  • Inadequate renal function defined as measured creatinine clearance less than 50 mL/min/1.73 m^2 based on the Cockcroft-Gault formula (adults) or Schwartz formula (age < 12 years). Adults: eCCr (mL/min/1.73 m^2) = (140 - age) x mass (kg) x (0.85 if female)/72 x serum creatinine (mg/dL; Children: eCCr (mL/min/1.73 m^2) = k x height (cm) / serum creatinine (mg/dL) k = 0.33 (pre-term), 0.45 (full term to 1 year old), 0.55 (age 1-12 years).
  • Inability to tolerate oral medications.
  • Absolute neutrophil count < 1500 per microliter.
  • Requirement for platelet transfusions other than to perform extracorporeal photopheresis.
  • Pregnancy.
  • Progressive or recurrent malignancy defined other than by quantitative molecular assays.
  • Known hypersensitivity to sirolimus.
Last Updated
October 25, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.