Conditions: Neural Tube Defects Anemia Leukemia, Myeloid Bone Marrow Transplant Failure Myelodysplastic Syndromes (MDS) Myeloproliferative Disorders
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 44
Healthy volunteers: no

Brief summary:
Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a treatment option for patients with myelodysplasia or myeloproliferative Disorders. During the course of this study, it will be evaluated whether a particular type of blood cell, called a cytokine-induced killer (CIK) cell, may add benefit to allogeneic stem cell transplantation. CIK cells are present in small quantities in the bloodstream but their numbers can be expanded after a brief period of nurturing in a laboratory.

Detailed description:
Primary Objectives:

To determine the rate of conversion to FDC following infusion of allogeneic CIK cells among patients with MDS, therapy-related myeloid neoplasms, or MPD who receive non myeloablative preparative regimen of TLI / ATG followed by allogeneic HCT and consolidation with allogeneic CIK cells.

Secondary Objectives:

* To determine the 2 year overall survival (OS) and event free survival (EFS)
* To determine the incidence of acute GVHD following infusion of allogeneic CIK cells
* To assess the pre-transplant expression of NKG2D ligands in patients' bone marrow aspirates.

Arms:
arm 1: Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.

Interventions: intervention 1: CIK cells intervention 2: Cyclosporine intervention 3: Mycophenolate Mofetil intervention 4: Thymoglobulin intervention 5: Total Lymphoid Irradiation (TLI)
Intervention descriptions: intervention 1: Standard of care intervention 2: 5 mg/kg, po intervention 3: 15 mg/kg, oral intervention 4: 7.5 mg/kg, IV intervention 5: None

Protocol document: