Non Hodgkin Lymphoma Clinical Trial
Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT
Summary
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)
Full Description
To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft-vs-host disease (GvHD) prevention in human leukocyte antigen (HLA)-matched related donor peripheral blood stem cell (PBSC) or marrow transplantation (BMT), collectively hematopoietic stem cell transplantation (HSCT). This study will report the toxicities associated with this drug combination.
For all treatments and procedures, Study Day is based on the day of HSCT as Day 0.
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).
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There is 1 Location for this study
Stanford California, 94305, United States
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