Non Hodgkin Lymphoma Clinical Trial
Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT
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
Full Description
To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft versus host disease (GVHD) prevention in HLA matched related donor blood or marrow transplantation (BMT). This study will report the toxicities associated with this drug combination and also explore possible correlations between specific blood cell types and antibody production during this therapy.
Eligibility 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.
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There is 1 Location for this study
Stanford California, 94305, United States
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