A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies
Primary Purpose
Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Myelodysplastic Syndromes
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CliniMACS CD34 Reagent System
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Myeloid Malignancies, Bone Marrow Transplant, AML, ALL, MDS, CML
Eligibility 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
Sites / Locations
- Indiana University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alloreactive NK cell infusion
Arm Description
Escalating doses of alloreactive NK cells.
Outcomes
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.
Secondary Outcome Measures
Assess toxicity associated with the infusion of alloreactive NK cells
Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.
Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.
Describe the frequency and type of infections occurring within the first year following transplantation.
Describe immune reconstitution following transplantation.
Full Information
NCT ID
NCT00569179
First Posted
December 5, 2007
Last Updated
August 28, 2015
Sponsor
Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00569179
Brief Title
A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic
Keywords
Myeloid Malignancies, Bone Marrow Transplant, AML, ALL, MDS, CML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alloreactive NK cell infusion
Arm Type
Experimental
Arm Description
Escalating doses of alloreactive NK cells.
Intervention Type
Device
Intervention Name(s)
CliniMACS CD34 Reagent System
Intervention Description
Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assess toxicity associated with the infusion of alloreactive NK cells
Time Frame
through Day 128
Title
Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.
Time Frame
through Day 128
Title
Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.
Time Frame
through Day 128
Title
Describe the frequency and type of infections occurring within the first year following transplantation.
Time Frame
through Day 128
Title
Describe immune reconstitution following transplantation.
Time Frame
through Day 128
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif Farag, MD, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies
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