Status:
TERMINATED
Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT
Lead Sponsor:
Stanford University
Conditions:
Hematologic Diseases
Acute-graft-versus-host Disease
Eligibility:
All Genders
2-60 years
Phase:
PHASE2
Brief 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 transplantatio...
Detailed 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 ce...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01220297
Start Date
August 1 2006
End Date
August 1 2011
Last Update
June 5 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305