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

Not Recruiting

Trial ID: NCT01220297

Purpose

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)

Official Title

Sirolimus and Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation

Stanford Investigator(s)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


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).

Intervention(s):

drug: Sirolimus

drug: Carmustine

drug: Mycophenolate mofetil (MMF)

drug: Etoposide

drug: Cyclophosphamide (Cyclo, CY)

drug: FTBI

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822

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