Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)

Completed · Phase 2/Phase 3

Conditions studied: Chronic GVHD

In brief

This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus 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 an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.

Key facts

Study ID

NCT01106833

Run by

Medical College of Wisconsin

People needed

151

Starts

2010-04-01

Expected to finish

2018-06-01

Last updated by the study team

2018-12-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Suitable candidates are patients with classic chronic GVHD or overlap syndrome (classic chronic plus acute GVHD)that is: a)Previously untreated (newly diagnosed) as defined by having received < 14 days of prednisone (or equivalent) before enrollment/randomization to study therapy; b)Previously treated but inadequately responding after ≤ 16 weeks of initial therapy with prednisone and/or calcineurin inhibitor (CNI) ± additional non-sirolimus agent (started at the time of chronic GVHD diagnosis).
• 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.

You may not qualify if…

• Patients with late persistent acute GVHD or recurrent acute GVHD only.
• Inability to begin prednisone therapy at a dose of greater than 0.5 mg/kg/day.
• Receiving sirolimus for treatment of chronic GVHD (sirolimus for prophylaxis or treatment of acute GVHD is acceptable).
• Already receiving sirolimus (for prophylaxis or treatment of acute GVHD) with prednisone at ≥ 0.25 mg/kg/day (or equivalent) ± additional agents.
• Receiving therapy for chronic GVHD for more than 16 weeks.
• 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 less than or equal to 12 years). Adults: estimated creatinine clearance rate (eCCr) (mL/min/) = (140 - age) x mass (kg) x (0.85 if female)/72 x serum creatinine (mg/dL; Creatinine clearance (mL/min/1.73m\^2) = eCCr x 1.73/Body Surface Area (BSA) (m\^2); 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 less than 1500 per microliter.
• Requirement for platelet transfusions.
• Pregnancy (positive serum β-HCG) or breastfeeding.
• Receiving any treatment for persistent, progressive or recurrent malignancy.
• Progressive or recurrent malignancy defined other than by quantitative molecular assays.
• Known hypersensitivity to sirolimus.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• University of Florida College of Medicine (Shands) — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Blood & Marrow Transplant Program at Northside Hospital — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University, Barnes Jewish Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Mayo Clinic — Rochester, New York, United States
• University of North Carolina Hospital at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Jewish Hospital BMT Program — Cincinnati, Ohio, United States
• University Hospitals of Cleveland/ Case Western — Cleveland, Ohio, United States
• University of Oklahoma Medical Center — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University (A) and (P) — Portland, Oregon, United States
• University of Pennsylvania Cancer Center — Philadelphia, Pennsylvania, United States
• Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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