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


Phase 2
50 Years
N/A
Open (Enrolling)
Both
Neural Tube Defects, Anemia, Leukemia, Myeloid, Bone Marrow Transplant Failure, Myelodysplastic Syndromes (MDS), Myeloproliferative Disorders

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

proportion of patients achieving full donor T cell chimerism by Day 90 post non-myeloablative allogeneic transplant with allogeneic CIK cells

Outcome Time Frame:

90 days

Safety Issue:

No

Principal Investigator

Jonathan Benjamin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT217

NCT ID:

NCT01392989

Start Date:

March 2011

Completion Date:

March 2013

Related Keywords:

  • Neural Tube Defects
  • Anemia
  • Leukemia, Myeloid
  • Bone Marrow Transplant Failure
  • Myelodysplastic Syndromes (MDS)
  • Myeloproliferative Disorders
  • Anemia
  • Leukemia
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Neural Tube Defects
  • Spinal Dysraphism

Name

Location

Stanford University School of MedicineStanford, California  94305-5317