Status:
COMPLETED
Pharmacokinetics-based Mycophenolate Mofetil Dosing for GVHD Prevention
Lead Sponsor:
University of Pittsburgh
Conditions:
Allogeneic Blood and Marrow Transplantation (BMT)
Graft Versus Host Disease
Eligibility:
All Genders
6-21 years
Phase:
PHASE2
Brief Summary
Bone marrow transplantation (BMT) is used to successfully treat high-risk forms of leukemia, lymphoma, and other childhood cancers that were once considered incurable. A major barrier to the applicati...
Detailed Description
Graft-versus-host disease (GVHD) remains a major barrier to the success of allogeneic blood and marrow transplant (BMT) therapy. Acute GVHD is seen in 30-80% of patients and once established, often re...
Eligibility Criteria
Inclusion
- Patients must be between 6 months and 21 years of age.
- Recipients of an allogeneic blood and marrow transplant (BMT).
- Stem cell sources should be bone marrow or umbilical cord blood.
- Bone marrow or cord blood unit: Sibling should be HLA matched at A, B and DRB1 loci. Unrelated cord blood unit should be at a minimum 4/6 matched at allele level on HLA A, B and DRB1 loci. Unrelated donor should be HLA allele level matched at A, B, C and DRB1 loci.
- Minimum prefreezing nucleated cell dose for cord blood units: 3x10\^7/kg for malignant diseases and 5x10\^7/kg for nonmalignant diseases.
- Conditioning regimen must be myeloablative in intensity. Examples include but are not limited to Cy/TBI, BuCy 200, etc.
- Patients ≥ 16 years old must have a Karnofsky score ≥ 70%, and patients \< 16 years old must have a Lansky score ≥ 70%.
- Renal: Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2.
- Hepatic: Total bilirubin ≤ 2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert's syndrome; and SGOT (AST), SGPT (ALT), and Alkaline Phosphatase \< 5 x upper limit of normal (ULN) for age.
- Cardiac: Left ventricular ejection fraction at rest \> 40%, or shortening fraction \> 26%, by echocardiogram or radionuclide scan.
- Pulmonary: FEV1, FVC, and DLCO (diffusion capacity) \> 50% of predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation \> 92% of room air.
Exclusion
- Patients with a known hypersensitivity to MMF.
- Prior autologous or allogeneic BMT \< 12 months prior to enrollment.
- Mismatched related donor.
- Mismatched unrelated marrow donor.
- Peripheral blood stem cell source.
- Reduced intensity conditioning.
- Uncontrolled bacterial, viral, fungal or other infection.
- Evidence of HIV infection or HIV positive serology.
- Requirement of supplemental oxygen.
- Patients who are pregnant (B-hCG positive) or breastfeeding. All females of 11 years of age or older and/or who have begun menstruating will be screened for hCG by either urinalysis or a blood sample in order to screen for pregnancy status, as per institutional BMT policy.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01487577
Start Date
June 1 2010
End Date
January 1 2016
Last Update
June 21 2016
Active Locations (1)
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1
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224