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

Indiana University School of Medicine

Status and phase: Terminated; Phase 1

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

Treatments: Device: CliniMACS CD34 Reagent System

Study type: Interventional

Funder types: Other

Identifiers

NCT00569179

0612-26/ IUCRO-0179

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Alloreactive NK cell infusion

Experimental group

Description:

Escalating doses of alloreactive NK cells.

Treatment:

Device: CliniMACS CD34 Reagent System