Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant
Completed · Phase 2
Conditions studied: Hematologic Neoplasms
In brief
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 regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune reconstitution, thereby improving the safety of the procedure. The past experience with post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism, which the investigators hope will translate into improved disease control through the well documented graft-versus-malignancy effects of donor T cells.
Key facts
- Study ID
- NCT01244906
- Run by
- Northside Hospital, Inc.
- People needed
- 26
- Starts
- 2010-12-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-05-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northside Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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