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A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies

This study is currently recruiting participants.
Verified February 2013 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00569179
First received: December 5, 2007
Last updated: March 4, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.


Condition Intervention Phase
Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Myelodysplastic Syndromes
Leukemia, Myelogenous, Chronic
 Device: CliniMACS CD34 Reagent System
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies. [ Time Frame: through Day 128 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess toxicity associated with the infusion of alloreactive NK cells [ Time Frame: through Day 128 ] [ Designated as safety issue: Yes ]
  • Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells. [ Time Frame: through Day 128 ] [ Designated as safety issue: No ]
  • Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses. [ Time Frame: through Day 128 ] [ Designated as safety issue: No ]
  • Describe the frequency and type of infections occurring within the first year following transplantation. [ Time Frame: through Day 128 ] [ Designated as safety issue: No ]
  • Describe immune reconstitution following transplantation. [ Time Frame: through Day 128 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2007
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alloreactive NK cell infusion
Escalating doses of alloreactive NK cells.
 Device: CliniMACS CD34 Reagent System
Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically documented AML, ALL, MDS, CML,
  • Identification of haploidentical donor
  • LVEF > 45% corrected
  • DLCO > 50% predicted
  • Serum Creatinine <= 2 mg/dL
  • Bilirubin < 2 x ULN
  • AST, ALT < 2 x ULN
  • Age ≤ 65 years
  • Performance Status 0-1

Exclusion Criteria:

  • Patients relapsing <6 months after autologous SCT are not eligible.
  • Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection
  • No HIV disease
  • Non-pregnant and non-nursing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569179

Contacts
Contact: Lisa Wood, RN 317-944-1781 llwood@iupui.edu
Contact: Sherif Farag, MD, PhD 317-274-0843 ssfarag@iupui.edu

Locations
United States, Indiana
Indiana University Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lisa Wood, RN     317-944-1781     llwood@iupui.edu    
Contact: Sherif Farag, MD, PhD     317-274-0843     ssfarag@iupui.edu    
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Sherif Farag, MD, PhD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00569179     History of Changes
Other Study ID Numbers: 0612-26/ IUCRO-0179
Study First Received: December 5, 2007
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
Myeloid Malignancies
Bone Marrow Transplant
AML
 ALL
MDS
CML

Additional relevant MeSH terms:
Neoplasms
Leukemia
Leukemia, Lymphoid
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on May 23, 2013