Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/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, 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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: CIK cells
- drug: Cyclosporine
- drug: Mycophenolate Mofetil
- drug: Thymoglobulin
- radiation: Total Lymphoid Irradiation (TLI)
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
Ages Eligible for Study
50 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Physician Referrals
650-723-0822
Not Recruiting
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