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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Everett Meyer, Stanford University
ClinicalTrials.gov Identifier:
NCT01392989
First received: June 21, 2011
Last updated: July 10, 2014
Last verified: July 2014

June 21, 2011
July 10, 2014
March 2011
May 2015   (final data collection date for primary outcome measure)
proportion of patients achieving full donor T cell chimerism by Day 90 post non-myeloablative allogeneic transplant with allogeneic CIK cells [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01392989 on ClinicalTrials.gov Archive Site
  • OS (Overall survival); incidence of acute Graft versus host disease following CIK infusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • EFS (Event Free Survival); incidence of acute Graft versus host disease following CIK infusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Post T-plant Infusion of Allogeneic Cytokine Induced Killer Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
Post Transplant Infusion of Allogeneic Cytokine Induced Killer Cells as Consolidative Therapy After Non-Myeloablative Allogeneic Transplantation in Patients With Myelodysplasia or 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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neural Tube Defects
  • Anemia
  • Leukemia, Myeloid
  • Bone Marrow Transplant Failure
  • Myelodysplastic Syndromes (MDS)
  • Myeloproliferative Disorders
  • Drug: CIK cells
    Standard of care
    Other Name: Cytokine-induced Killer Cells
  • Drug: Cyclosporine
    5 mg/kg, po
    Other Names:
    • cyclosporine
    • cyclosporin
    • cyclosporin A
  • Drug: Mycophenolate Mofetil
    15 mg/kg, oral
    Other Names:
    • MMF
    • CellCept
  • Drug: Thymoglobulin
    7.5 mg/kg, IV
    Other Names:
    • Anti-thymocyte globulin
    • ATG
Experimental: Allogeneic Cytokine Induced Killer Cells
Target dose of ≥ 5 x 106 CD34+ cells/kg of recipient body weight plus an additional 2 x109 mononuclear cells.
Interventions:
  • Drug: CIK cells
  • Drug: Cyclosporine
  • Drug: Mycophenolate Mofetil
  • Drug: Thymoglobulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
21
May 2017
May 2015   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
United States
 
NCT01392989
BMT217, SU-04202010-5724, 18127
Yes
Everett Meyer, Stanford University
Everett Meyer
Not Provided
Principal Investigator: Everett Meyer Stanford University
Stanford University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP