Sirolimus and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis in Myeloablative Matched Related Donor Hematopoietic Cell Transplantation
1. Acute myelogenous leukemia (AML):
- Age 2-60 years beyond 2nd remission or relapsed/refractory disease.
- Age 51-60 years of age, in first or subsequent remission or relapsed/refractory
- AML with multilineage dysplasia
2. Acute lymphoblastic leukemia (ALL):
- Age 2-60 years beyond 2nd remission or relapsed/refractory disease
- Age 51-60 years in first or subsequent remission or relapsed/refractory disease
3. Chronic myelogenous leukemia (CML), beyond 2nd chronic phase or in blast crisis
4. Myelodysplastic syndrome (MDS) including patients with World Health Organization
(WHO) refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related
5. Myeloproliferative disorders with poor long- term survival including myeloid
metaplasia and myelofibrosis
6. Non-hodgkin lymphoma (NHL) - High risk NHL in first remission - Relapsed or
7. Hodgkin lymphoma beyond first remission
1. Patients 2-60 years of age
2. Matched related donor identified, 6/6 HLA-A, B and DRB1
3. Karnofsky performance status >= 70% or Lansky performance status >= 70% or patients <
16 years old.
4. Willingness and ability to take oral medications in pill form during the
5. Informed consent
Exclusion Criteria:1. Prior myeloablative, allogeneic or autologous HCT. 2. HIV
infection 3. Pregnant or lactating patients 4. Evidence of uncontrolled active infection
5. Renal function: serum creatinine >1.5 mg/dl or 24 hour creatinine clearance > 50
6. Hepatic function: direct bilirubin, ALT or AST > 2 x upper limit of normal 7.
Pulmonary function: In adults, corrected diffusing capacity (DLCO) < 60% predicted and in
children, room air oxygen saturation <92%.
8. Cardiac function: In adults, left ventricular ejection fraction < 45% and in
children, shortening fraction < 26%.
9. Fasting Cholesterol > 300 mg/dl or Triglycerides >300 gm/dl while on lipid-lowering
10.Patients receiving other investigational drugs unless cleared by the Principal
11. Patients with prior malignancies except basal cell carcinoma or treated carcinoma
in-situ. Cancer treated with curative intent > 5 years will be allowed. Cancer treated
with curative intent d 5 years will not be allowed without Protocol Chair approval.