Myelodysplastic Syndrome Clinical Trial
Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
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.
Full 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.
Eligibility Criteria
INCLUSION CRITERIA, RECIPIENT WITH MYELODYSPLASTIC SYNDROME (MDS)
Diagnosis of MDS classifiable by the World Health Organization (WHO) on the basis of:
Refractory anemia
Refractory anemia with excess blasts-1
Refractory anemia with excess blasts-2
Refractory cytopenia with multi-lineage dysplasia
Refractory cytopenia with multi-lineage dysplasia and ringed sideroblasts
Chronic myelomonocytic leukemia (CMML)
MDS transformed to acute leukemia
MDS-unclassified
Participants with advanced MDS must have < 10% marrow blasts prior to receiving conditioning with TLI/ATG, documented by marrow examination within 1 month prior.
Participants with evolution to acute leukemia (AML) must be in a morphologic leukemia free-state (MLFS) with blasts < 5%
INCLUSION CRITERIA, RECIPIENT WITH MYELOPROLIFERATIVE DISORDER (MPD)
Diagnosis of MPD on the basis of:
Idiopathic myelofibrosis
Polycythemia vera
Essential thrombocythemia
Chronic myelomonocytic leukemia (CML)
CML, Philadelphia chromosome-negative
Chronic neutrophilic leukemia
Chronic eosinophilic leukemia
Hypereosinophilic cyndrome
Systemic mastocytosis
< 10% marrow blasts prior to receiving conditioning with TLI/ATG, documented by marrow examination within 1 month prior.
Participants with evolution to acute leukemia (AML) must be in a morphologic leukemia free-state (MLFS) with blasts < 5%. Presence of residual dysplastic features following cytoreductive therapy is acceptable.
INCLUSION CRITERIA, RECIPIENT WITH THERAPY-RELATED MYELOID NEOPLASM (t MDS)
< 10% marrow blasts prior to receiving conditioning with TLI/ATG, documented by marrow examination within 1 month prior.
Morphologic leukemia free-state with blasts < 5 %.
Age > 50 years, or < 50 years of age but at high-risk for regimen-related toxicity associated with conventional myeloablative transplants due to pre-existing medical conditions or prior therapy
Availability of a fully HLA-matched or single antigen/allele mismatched sibling or unrelated donor
Prior malignancy diagnosed > 5 years ago without evidence of disease, or < 5 years ago with life expectancy of > 5 years are eligible (prior malignancy is not a requirement)
INCLUSION CRITERIA, DONOR
Donors must be HLA-matched or one allele mismatched.
Donor age < 75 (EXCEPTION by Principal Investigator discretion)
Must consent to PBSC mobilization with G-CSF; apheresis; and collection and donation of plasma
Donor must consent to placement of a central venous catheter in the event that peripheral venous access is limited.
EXCLUSION CRITERIA, RECIPIENT
Any of the following:
Uncontrolled CNS involvement with disease
Pregnant
Cardiac function: ejection fraction (EF) < 35% or uncontrolled cardiac failure
Diffusing capacity of the lungs for carbon monoxide (DLCO) < 40% predicted
Bilirubin > 3 mg/dL
Aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN)
Alanine aminotransferase (ALT) > 3x ULN
Estimated creatinine clearance < 50 mL/min
Karnofsky performance score (KPS) < 70%
Documented fungal disease that is progressive despite treatment
HIV-positive
EXCLUSION CRITERIA, DONOR
Any of the following:
Identical twin to recipient
Pregnant or lactating
Prior malignancy within the preceding 5 years (EXCEPTION: non-melanoma skin cancers)
HIV seropositivity
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There is 1 Location for this study
Stanford California, 94305, United States
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