Sirolimus and Mycophenolate Mofetil in Preventing GVHD in Patients With Hematologic Malignancies Undergoing HSCT

Not Recruiting

Trial ID: NCT02728700


This pilot phase I/II trial studies the side effects and how well sirolimus and mycophenolate mofetil work in preventing graft versus host disease (GvHD) in patients with hematologic malignancies undergoing hematopoietic stem cell transplant (HSCT). Biological therapies, such as sirolimus and mycophenolate mofetil, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Giving sirolimus and mycophenolate mofetil after hematopoietic stem cell transplant may be better in preventing graft-versus-host disease.

Official Title

Pilot Safety and Feasibility Trial of Mycophenolate and Sirolimus for Prevention of GVHD in Mismatched Unrelated and Related Donor Hematopoietic Stem Cell Transplantation for Hematologic Malignancies

Stanford Investigator(s)


Inclusion Criteria:

   - Subjects must have one of the following disease categories:

      - Acute myeloid leukemia (AML) beyond 2nd remission or relapsed/refractory disease

      - Acute lymphoblastic leukemia (ALL) beyond 2nd remission or relapsed/refractory

      - Chronic myeloid leukemia (CML) beyond 2nd chronic phase or in blast crises

      - Myelodysplastic syndrome (MDS)

      - Myeloproliferative disorders including myeloid metaplasia and myelofibrosis

      - High risk non-Hodgkin's lymphoma (NHL) in first remission

      - Relapsed or refractory NHL

      - Hodgkin's lymphoma (HL) beyond first remission

   - Performance status by Karnofsky of >= 70% or Lansky > 70% for patients < 16 years of

   - Human leukocyte antigen (HLA) mismatched related or unrelated donor identified 8/10 or

   - Willingness to take oral medications during the transplantation period

   - Willingness and ability to sign a written informed consent (assent if applicable)

Exclusion Criteria:

   - Prior myeloablative allogeneic or autologous HSCT

   - Human immunodeficiency virus (HIV) infection

   - Pregnant or lactating females

   - Evidence of uncontrolled active infection

   - Down syndrome

   - Serum creatinine (CR) < 1.5mg/dl or 24 hour CR clearance < 50 ml/min

   - Direct bilirubin > 2 x upper limit of normal (ULN)

   - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN

   - Carbon monoxide diffusing capability test (DLCO) > 60% predicted and in children- room
   air oxygen saturation > 92%

   - Left ventricular ejection fraction < 45% and in children-shortening fraction < 26%

   - Fasting cholesterol > 300 mg/dl or triglycerides > 300 while on lipid lowering agents

   - Patients who have received an investigational drug within 30 days of enrollment in

   - Patients with prior malignancies except basal cell carcinoma or treated carcinoma
   in-situ; cancer treated with curative intent > 5 years will be allowed; cancer
   treatment with curative intent =< 5 years will not be allowed


procedure: Allogeneic Hematopoietic Stem Cell Transplantation

other: Laboratory Biomarker Analysis

drug: Sirolimus

drug: Mycophenolate Mofetil

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Gopin Saini

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