Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT01106833
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01106833
Study Brief:
Protocol Section:
NCT01106833