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



Status:Terminated
Conditions:Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:August 2007
End Date:December 2010

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
Indiana University Cancer Center
Indianapolis, Indiana 46202
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mi
from
Indianapolis, IN
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