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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL

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

Details

• Lead Sponsor: Stanford University
• Collaborator: National Institutes of Health (NIH)
• Treatments: Busulfan; Carmustine; Cyclophosphamide; Etoposide; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

• Disease Categories: (one of the following)

• AML, age 2 - 60 years beyond 2nd remission or relapsed/refractory disease

• AML, age 51-60 years of age, in first or subsequent remission or relapsed/refractory disease

• AML with multilineage dysplasia

• ALL, age 2 - 60 years beyond 2nd remission or relapsed/refractory disease

• ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease

• CML Beyond 2nd chronic phase or in blast crisis

• MDS; Includes World Health Organization classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS

• Myeloproliferative disorders; MDS with poor long-term survival including myeloid metaplasia and myelofibrosis

• High risk NHL in first remission

• Relapsed or refractory NHL

• HL beyond first remission

• Males and females of any ethnic background 2 - 60 years of age

• Karnofsky Performance Status ≥ 70% or Lansky performance status > 70% for patients < 16 years of age.

• Matched related donor identified: 6/6 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 HCT

• HIV infection

• Pregnant

• Lactating females

• Evidence of uncontrolled active infection

• Organ Dysfunction:

• Serum creatinine > 1.5 mg/dL or 24 hour creatinine clearance < 50 ml/min

• Direct bilirubin, ALT or AST > 2 x ULN

• In adults DLCO < 60% predicted and in children room air oxygen saturation < 92%

• In adults, left ventricular ejection fraction < 45% and in children, shortening fraction < 26%

• Fasting Cholesterol > 300 mg/dL or Triglycerides > 300 mg/dL while on lipid-lowering agents.

• Patients receiving investigational drugs unless cleared by the PI.

• 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 ≤ 5 years will not be allowed with PI approval.