Trial Search Results

Sirolimus and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis in Myeloablative Matched Related Donor Hematopoietic Cell Transplant

To evaluate the incidence of grade II-IV acute GVHD with sirolimus and mycophenolate mofetil GVHD prophylaxis.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Institutes of Health (NIH)

Intervention(s):

  • Drug: Sirolimus
  • Drug: Mycophenolate Mofetil

Phase:

Phase 2

Eligibility


Inclusion Criteria:Diagnoses Included:

   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
      disease

      - 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 MDS

   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 refractory
   NHL

   7. Hodgkin lymphoma beyond first remission

Other Inclusion Criteria:

   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
   transplantation period.

   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 ml/min.

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
agents.

10.Patients receiving other investigational drugs unless cleared by the Principal
Investigator.

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.

Ages Eligible for Study

2 Years - 60 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822
Not Recruiting