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

Sponsor:	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

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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Myelodysplastic Syndromes

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)

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	317-944-1781	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:	Sherif Farag, MD/ Principal Investigator, Indiana University Cancer Center
ClinicalTrials.gov Identifier:	NCT00569179 History of Changes
Other Study ID Numbers:	0612-26/ IUCRO-0179
Study First Received:	December 5, 2007
Last Updated:	January 31, 2012
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 February 09, 2012