Status:
COMPLETED
Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant
Lead Sponsor:
Northside Hospital, Inc.
Collaborating Sponsors:
Blood and Marrow Transplant Group of Georgia
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative reg...
Eligibility Criteria
Inclusion
- Availability of a 7/8 or 8/8 (HLA-A, B, C, DR) related or unrelated donor
- 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
- Poor cardiac function (EF \<40%)
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01244906
Start Date
December 1 2010
End Date
December 1 2014
Last Update
May 1 2015
Active Locations (1)
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1
Northside Hospital
Atlanta, Georgia, United States, 30342