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Post Transplant Infusion of Allogeneic Cytokine Induced Killer Cells as Consolidative Therapy After Non-Myeloablative Allogeneic Transplantation in Patients With Myelodysplasia or Myeloproliferative Disorders

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, we will attempt to learn 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.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : CIK cells
  • drug : Thymoglobulin
  • drug : Mycophenolate Mofetil
  • drug : Cyclosporine

Phase: Phase 2

Eligibility

Ages Eligible For Study:

50 Years - N/A

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.

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822
Not Recruiting

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