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

• Status: Completed
• Trial end date: 2017-03-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Everett Meyer
• Treatments: Antilymphocyte Serum; Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid; Thymoglobulin

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