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

Phase 1

Terminated

• Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic; Leukemia, Lymphoid
• Interventions: Device: CliniMACS CD34 Reagent System

• Registration Number: NCT00569179
• Lead Sponsor: Indiana University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-07
• Primary Completion: 2010-04
• Study Completion: 2010-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-28
• Last Update Posted: 2015-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alloreactive NK cell infusion	CliniMACS CD34 Reagent System	Escalating doses of alloreactive NK cells.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Describe immune reconstitution following transplantation.	through Day 128
Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.	through Day 128
Assess toxicity associated with the 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

Trial Locations

Locations (1)

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States