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

Sponsor

Indiana University School of Medicine (Other)

Overall Status

Terminated

CT.gov ID

NCT00569179

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Acute Leukemia, Lymphoid Myelodysplastic Syndromes Leukemia, Myelogenous, Chronic	Device: CliniMACS CD34 Reagent System	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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. [through Day 128]

Secondary Outcome Measures

Assess toxicity associated with the infusion of alloreactive NK cells [through Day 128]
Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells. [through Day 128]
Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses. [through Day 128]
Describe the frequency and type of infections occurring within the first year following transplantation. [through Day 128]
Describe immune reconstitution following transplantation. [through Day 128]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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