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

Stopped early · Phase 1

Conditions studied: Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic

In brief

The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.

Key facts

Study ID

NCT00569179

Run by

Indiana University

People needed

1

Starts

2007-08-01

Expected to finish

2010-12-01

Last updated by the study team

2015-08-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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