Post T-plant Infusion of Allogeneic Cytokine Induced Killer Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders

Inclusion Criteria:

4.1.1 Recipient Inclusion Criteria to start ATG/TLI:

Diagnosis Myelodysplastic Syndrome Criteria

(A) Diagnosis of MDS classifiable by the WHO system as

- Refractory Anemia

- Refractory Cytopenia with Multilineage Dysplasia

- MDS-unclassified

- Refractory Cytopenias with Multilineage Dysplasia and Ringed Sideroblasts, Refractory
Anemia with Excess Blasts-1

- Refractory Anemia with Excess Blasts-2

- Chronic myelomonocytic leukemia (CMML)

- MDS transformed to acute leukemia.

Patients with advanced MDS must have < 10% marrow blasts prior to receiving conditioning
with TLI/ATG. Less than 10% marrow blasts must be documented by marrow examination within 1
month of starting conditioning. If necessary, a cytoreductive regimen will be determined by
referring centers.

Patients with evolution to AML are required to be in a morphologic leukemia free-state with
blasts < 5% (50).

Myeloproliferative Disorders

B) Myeloproliferative disorders to be included:

- Idiopathic Myelofibrosis

- Polycythemia vera

- Essential Thrombocythemia

- Chronic Myelomonocytic Leukemia

- Chronic Neutrophilic Leukemia

- Chronic Eosinophilic Leukemia

- Philadelphia chromosome-negative CML.

- Hypereosinophilic Syndrome

- Systemic Mastocytosis

Patients with MPD must have < 10% marrow blasts prior to receiving conditioning with
TLI/ATG. Less than 10% marrow blasts must be documented by marrow examination within 1
month of starting conditioning. If necessary, a cytoreductive regimen will be determined by
referring centers.

Patients with evolution to AML are required to be in a morphologic leukemia-free state less
than 5% in a marrow aspirate. Presence of residual dysplastic features following
cytoreductive therapy is acceptable.

Therapy-related myeloid neoplasms

Patients with t-MDS must have < 10% marrow blasts prior to receiving conditioning with
TLI/ATG. Less than 10% marrow blasts must be documented by marrow examination within 1
month of starting conditioning. If necessary, a cytoreductive regimen will be determined by
referring centers.

Patients with t-AML are required to be in a morphologic leukemia free-state with blasts < 5
%.

2. Patient age > 50 years, or for patients < 50 years of age but because of pre-existing
medical conditions or prior therapy are considered to be at high risk for regimen-related
toxicity associated with conventional myeloablative transplants.

3. A fully HLA matched or single antigen/allele mismatched sibling or unrelated donor is
available.

4.2 Donor Eligibility

4.2.1 Inclusion Criteria - Related Donors

1. Donors must be HLA-matched or one allele mismatched.

2. Donor age < 75 unless cleared by the Principal Investigator

3. Donor must consent to peripheral blood stem cells (PBSC) mobilization with G-CSF and
apheresis

4. Donor must consent to placement of a central venous catheter in the event that
peripheral venous access is limited.

Exclusion Criteria:

4.1.2 Recipient Exclusion Criteria

1. Uncontrolled CNS involvement with disease

2. Females who are pregnant

3. Organ dysfunction defined as follows:

- Cardiac function: ejection fraction (EF) < 35% or uncontrolled cardiac failure

- Pulmonary: DLCO < 40% predicted

- Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or AST or
ALT > 3x the upper limit of normal

- Estimated creatinine clearance < 50 ml/min

4. Karnofsky performance score (KPS) < 70% (Appendix F)

5. Documented fungal disease that is progressive despite treatment

6. Viral infections: HIV positive patients are not eligible for this protocol. Hepatitis
B and C positive patients will be evaluated on a case-by-case basis

7. Patients with prior malignancies diagnosed > 5 years ago without evidence of disease
are eligible. Patients with a prior malignancy treated < 5 years ago but have a life
expectancy of > 5 years for that malignancy are eligible.

4.1.3 Recipient Exclusion Criteria to proceed to CIK infusion 1. Uncontrolled infection 2.
Evidence of disease relapse 3. Grade 2 or above GVHD (Grade 1 GVHD to be evaluated by
Principal Investigator) 4. Does not meet release criteria for CIK cells

.2.2 Exclusion Criteria - Related Donor

1. Identical twin

2. Pregnant or lactating females

3. Prior malignancy within the preceding five years, with the exception of non-melanoma
skin cancers.

4. HIV seropositivity

4.2.3 Unrelated Donor Inclusion Criteria

1. Donors must be HLA-matched or one allele or antigen mismatched.

2. Donor must consent to PBSC mobilization with G-CSF and apheresis as well as collection
and donation of plasma. Bone marrow unrelated donors are not eligible for this
protocol.