Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant

Northside Hospital, Inc.

Status and phase: Completed; Phase 2

Conditions: Hematologic Neoplasms

Treatments: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01244906

NSH 911

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Reduced Intensity Allogeneic Stem Cell Transplantation

Experimental group

Description:

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.

Treatment:

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation