A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Mallignancies - Full Text View

Sponsored by:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00569179

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 I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
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

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 2011
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

CD34+ Selection of Allogeneic Peripheral Blood Stem Cells

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	317-274-1781	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 317-274-1781 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

Find a Clinical Trial This link exits the ClinicalTrials.gov site

Responsible Party:	Indiana University Cancer Center ( Sherif Farag, MD/ Principal Investigator )
Study ID Numbers:	0612-26/ IUCRO-0179
Study First Received:	December 5, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00569179
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indiana University:

Myeloid Malignancies
Bone Marrow Transplant
AML

ALL
MDS
CML

Study placed in the following topic categories:

Myelodysplastic syndromes
Leukemia, Lymphoid
Immunoproliferative Disorders
Precancerous Conditions
Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Myeloproliferative Disorders

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Preleukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoproliferative Disorders
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease

Neoplasms by Histologic Type
Immune System Diseases
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009