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.

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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.

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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

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT01392989

Recruitment Status:

Completed

Sponsor:

Everett Meyer

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There is 1 Location for this study

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Stanford University School of Medicine
Stanford California, 94305, United States

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Estimated Enrollment:

44

Study ID:

NCT01392989

Recruitment Status:

Completed

Sponsor:


Everett Meyer

How clear is this clinincal trial information?

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