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

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