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

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Carmustine; Cyclophosphamide; Etoposide; Etoposide phosphate; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

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).