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TerminatedNCT00569179Updated Aug 31, 2015

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

A Phase 1 interventional study of CliniMACS CD34 Reagent System in Leukemia, Myeloid, Acute, Leukemia, Lymphoid and Myelodysplastic Syndromes, sponsored by Indiana University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-08-31.

Sponsored by Indiana University School of Medicine · Phase 1, Interventional, and Treatment

Why this study was terminated
Slow accrual
Phase
Phase 1
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Myeloid Malignancies
  • Bone Marrow Transplant
  • AML
  • ALL
  • MDS
  • CML
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 1 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Alloreactive NK cell infusion

    Escalating doses of alloreactive NK cells.

    Device: CliniMACS CD34 Reagent System

Interventions

  • DeviceCliniMACS 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.

06

What researchers measure

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.

    Time frame: through Day 128

Secondary outcomes

  1. Assess toxicity associated with the infusion of alloreactive NK cells

    Time frame: through Day 128

  2. Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.

    Time frame: through Day 128

  3. Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.

    Time frame: through Day 128

  4. Describe the frequency and type of infections occurring within the first year following transplantation.

    Time frame: through Day 128

  5. Describe immune reconstitution following transplantation.

    Time frame: through Day 128

07

Study locations

1 site
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00569179
Lead sponsor
Indiana University School of Medicine
Responsible party
Sponsor
First posted
Dec 7, 2007
Start date
Aug 2007
Primary completion
Apr 2010
Completion
Dec 2010
Last update
Aug 31, 2015

Study contacts

Sherif Farag, MD, PhD
principal investigator · Indiana University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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