Trial Search Results
Post T-plant Infusion of Allogeneic Cytokine Induced Killer 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, 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 currently not accepting patients for this trial.
Lead Sponsor:
Everett Meyer
Stanford Investigator(s):
Intervention(s):
- Drug: CIK cells
- Drug: Cyclosporine
- Drug: Mycophenolate Mofetil
- Drug: Thymoglobulin
Phase:
Phase 2
Eligibility
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.
Exclusion Criteria:
4.1.2 Recipient Exclusion Criteria
1. Uncontrolled CNS involvement with disease
2. Females who are pregnant
3. Organ dysfunction defined as follows:
- Cardiac function: ejection fraction (EF) < 35% or uncontrolled cardiac failure
- Pulmonary: DLCO < 40% predicted
- Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or AST or
ALT > 3x the upper limit of normal
- Estimated creatinine clearance < 50 ml/min
4. Karnofsky performance score (KPS) < 70% (Appendix F)
5. Documented fungal disease that is progressive despite treatment
6. Viral infections: HIV positive patients are not eligible for this protocol. Hepatitis
B and C positive patients will be evaluated on a case-by-case basis
7. Patients with prior malignancies diagnosed > 5 years ago without evidence of disease
are eligible. Patients with a prior malignancy treated < 5 years ago but have a life
expectancy of > 5 years for that malignancy are eligible.
4.1.3 Recipient Exclusion Criteria to proceed to CIK infusion 1. Uncontrolled infection 2.
Evidence of disease relapse 3. Grade 2 or above GVHD (Grade 1 GVHD to be evaluated by
Principal Investigator) 4. Does not meet release criteria for CIK cells
.2.2 Exclusion Criteria - Related Donor
1. Identical twin
2. Pregnant or lactating females
3. Prior malignancy within the preceding five years, with the exception of non-melanoma
skin cancers.
4. HIV seropositivity
4.2.3 Unrelated Donor Inclusion Criteria
1. Donors must be HLA-matched or one allele or antigen mismatched.
2. Donor must consent to PBSC mobilization with G-CSF and apheresis as well as collection
and donation of plasma. Bone marrow unrelated donors are not eligible for this
protocol.
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