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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:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00569179
First received: December 5, 2007
Last updated: August 28, 2015
Last verified: August 2015
  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: 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:

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Responsible Party: 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: August 28, 2015

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

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

ClinicalTrials.gov processed this record on April 27, 2017