Post-transplant Cyclophosphamide and Sirolimus Following RIC Transplant
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | December 2010 |
| End Date: | December 2013 |
| Contact: | Scott R Solomon, MD |
| Email: | ssolomon@bmtga.com |
| Phone: | 404-255-1930 |
A Phase II Trial of Post-Transplant Cyclophosphamide and Sirolimus for Graft-versus-host Disease (GVHD) Prophylaxis Following Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation
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.
Inclusion Criteria:
- 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 Criteria:
- 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
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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