- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00569179
A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies
August 28, 2015 updated by: Indiana University School of Medicine
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
The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alloreactive NK cell infusion
Escalating doses of alloreactive NK cells.
|
Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
through Day 128
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess toxicity associated with the infusion of alloreactive NK cells
Time Frame: through Day 128
|
through Day 128
|
Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.
Time Frame: through Day 128
|
through Day 128
|
Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.
Time Frame: through Day 128
|
through Day 128
|
Describe the frequency and type of infections occurring within the first year following transplantation.
Time Frame: through Day 128
|
through Day 128
|
Describe immune reconstitution following transplantation.
Time Frame: through Day 128
|
through Day 128
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sherif Farag, MD, PhD, Indiana University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 5, 2007
First Submitted That Met QC Criteria
December 5, 2007
First Posted (Estimate)
December 7, 2007
Study Record Updates
Last Update Posted (Estimate)
August 31, 2015
Last Update Submitted That Met QC Criteria
August 28, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Neoplasms
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Leukemia, Lymphoid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Other Study ID Numbers
- 0612-26/ IUCRO-0179
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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