Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT
Hematologic Diseases, Acute-graft-versus-host Disease, Leukemia
About this trial
This is an interventional treatment trial for Hematologic Diseases
Eligibility Criteria
INCLUSION CRITERIA Acute myelogenous leukemia (AML), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years AML, in first or subsequent remission or relapsed/refractory disease, age 51 to 60 years of age AML with multilineage dysplasia Acute lymphoblastic leukemia (ALL), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease Chronic myeloid leukemia (CML), beyond 2nd chronic phase or in blast crisis Myelodysplastic syndrome (MDS), including World Health Organization (WHO)classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS MDS with poor long-term survival including myeloid metaplasia and myelofibrosis Myeloproliferative disorders High-risk non-Hodgkin lymphoma (NHL) in 1st emission Relapsed or refractory NHL Hodgkin lymphoma (HL) beyond first remission Males and females of any ethnic background, 2 to 60 years of age Karnofsky Performance Status (KPS) ≥ 70% or Lansky performance status > 70% for patients < 16 years of age. Related, matched-donor identified [6/6 human leukocyte antigen (HLA)-A, B and DRB1] Willingness to take oral medications during the transplantation period Ability to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA Prior myeloablative allogeneic or autologous hematopoietic stem cell transplant (HSCT) HIV infection Pregnant Lactating Evidence of uncontrolled active infection Serum creatinine > 1.5 mg/dL or 24-hour creatinine clearance < 50 mL/min Direct bilirubin, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN) Carbon monoxide diffusing capacity (DlCO) < 60% predicted (adults) OR and in-room air oxygen saturation < 92% (children) Left ventricular ejection fraction < 45% (adults) OR shortening fraction < 26%(children) Fasting cholesterol > 300 mg/dL or Triglycerides > 300 mg/dL while on lipid-lowering agents. Receiving investigational drugs unless cleared by the Principal Investigator (PI). Prior malignancies except basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent ≤ 5 years (EXCEPTION BY PI DISCRETION) (Cancer treated with curative intent > 5 years will be allowed).
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Carmustine Etoposide Cyclophosphamide
FTBI + Cyclophosphamide
Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
FTBI + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.