Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant
NCT ID: NCT01244906
Last Updated: 2015-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2010-12-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Reduced Intensity Allogeneic Stem Cell Transplantation
All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Allogeneic Hematopoietic Stem Cell Transplantation
Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Interventions
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Allogeneic Hematopoietic Stem Cell Transplantation
Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Eligibility Criteria
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Inclusion Criteria
* Age 18-75
* One of the following high-risk malignancies
* Chronic Myelogenous Leukemia
* Acute Myelogenous Leukemia
* Myelodysplastic Syndrome
* Myelofibrosis
* Acute Lymphocytic Leukemia
* Acute Lymphoblastic Lymphoma
* Chronic Lymphocytic Leukemia
* Prolymphocytic Leukemia
* Low-grade non-Hodgkin's Lymphoma
* Mantle Cell Lymphoma
* Hodgkin Lymphoma
* Myeloma
Exclusion Criteria
* Poor pulmonary function (FEV1 and FVC \<50% predicted)
* Poor liver function (bilirubin \>/= 2 mg/dl not due to hemolysis, Gilbert's or primary malignancy)
* Poor renal function (creatinine \>/= 2 mg/dl or creatinine clearance \<40mL/min)
* Karnofsky status \<70%
* HIV positive
18 Years
75 Years
ALL
No
Sponsors
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Blood and Marrow Transplant Group of Georgia
OTHER
Northside Hospital, Inc.
OTHER
Responsible Party
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Principal Investigators
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Scott R Solomon, MD
Role: PRINCIPAL_INVESTIGATOR
Blood and Marrow Transplant Group of Georgia
Locations
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Northside Hospital
Atlanta, Georgia, United States
Countries
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References
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Rieger K, Loddenkemper C, Maul J, Fietz T, Wolff D, Terpe H, Steiner B, Berg E, Miehlke S, Bornhauser M, Schneider T, Zeitz M, Stein H, Thiel E, Duchmann R, Uharek L. Mucosal FOXP3+ regulatory T cells are numerically deficient in acute and chronic GvHD. Blood. 2006 Feb 15;107(4):1717-23. doi: 10.1182/blood-2005-06-2529. Epub 2005 Nov 8.
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Other Identifiers
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NSH 911
Identifier Type: -
Identifier Source: org_study_id
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