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

Not Recruiting

Trial ID: NCT01392989

Purpose

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.

Official Title

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

Stanford Investigator(s)

Lori Muffly
Lori Muffly

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Wes (Janice) Brown
Wes (Janice) Brown

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


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

Intervention(s):

drug: CIK cells

drug: Cyclosporine

drug: Mycophenolate Mofetil

drug: Thymoglobulin

radiation: Total Lymphoid Irradiation (TLI)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822

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