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

NCT00569179 | Terminated Phase 1 DMC

• 1 other identifier: 0612-26/ IUCRO-0179
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Myeloid Malignancies; Bone Marrow Transplant; AML; ALL; MDS; CML

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assess toxicity associated with the infusion of alloreactive NK cells

  through Day 128

• Assess the risk of acute and chronic GvHD following 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

• Describe immune reconstitution following transplantation.

  through Day 128

Study Arms (1)

Alloreactive NK cell infusion

EXPERIMENTAL

Escalating doses of alloreactive NK cells.

Device: CliniMACS CD34 Reagent System

Interventions

CliniMACS CD34 Reagent System DEVICE

Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.

Alloreactive NK cell infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sherif Farag, MD, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 7, 2007
• Study Start: August 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

US (1)