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

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569179
First Posted: December 7, 2007
Last Update Posted: August 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Indiana University ( Indiana University School of Medicine ):

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 ]

Secondary Outcome Measures:
  • Assess toxicity associated with the infusion of alloreactive NK cells [ Time Frame: through Day 128 ]
  • Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells. [ Time Frame: through Day 128 ]
  • Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses. [ Time Frame: through Day 128 ]
  • Describe the frequency and type of infections occurring within the first year following transplantation. [ Time Frame: through Day 128 ]
  • Describe immune reconstitution following transplantation. [ Time Frame: through Day 128 ]

Enrollment: 1
Study Start Date: August 2007
Study Completion Date: December 2010
Primary Completion Date: April 2010 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569179


Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Sherif Farag, MD, PhD Indiana University School of Medicine
  More Information

Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00569179     History of Changes
Other Study ID Numbers: 0612-26/ IUCRO-0179
First Submitted: December 5, 2007
First Posted: December 7, 2007
Last Update Posted: August 31, 2015
Last Verified: August 2015

Keywords provided by Indiana University ( Indiana University School of Medicine ):
Myeloid Malignancies
Bone Marrow Transplant
AML
ALL
MDS
CML

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