Trial Search Results

Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT

A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high risk non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL)

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University


  • Drug: Sirolimus
  • Drug: Mycophenolate mofetil (MMF)
  • Drug: Carmustine
  • Drug: Etoposide
  • Drug: Cyclophosphamide (Cyclo, CY)
  • Drug: FTBI


Phase 2



   - 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


   - 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 <

   - Fasting cholesterol > 300 mg/dL or Triglycerides > 300 mg/dL while on lipid-lowering

   - 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).

Ages Eligible for Study

2 Years - 60 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
Not Recruiting