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

Myelodysplastic Syndromes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00569179
• Other study ID #: 0612-26/ IUCRO-0179
• Status: Terminated
• Phase: Phase 1
• First received: December 5, 2007
• Last updated: August 28, 2015
• Start date: August 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Assess toxicity associated with the infusion of alloreactive NK cells		through Day 128	Yes
Secondary	Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.		through Day 128	No
Secondary	Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.		through Day 128	No
Secondary	Describe the frequency and type of infections occurring within the first year following transplantation.		through Day 128	No
Secondary	Describe immune reconstitution following transplantation.		through Day 128	No

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