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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


Phase 1
18 Years
65 Years
Open (Enrolling)
Both
Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

through Day 128

Safety Issue:

Yes

Principal Investigator

Sherif Farag, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

0612-26/ IUCRO-0179

NCT ID:

NCT00569179

Start Date:

August 2007

Completion Date:

August 2015

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia, Lymphoid
  • Myelodysplastic Syndromes
  • Leukemia, Myelogenous, Chronic
  • Myeloid Malignancies
  • Bone Marrow Transplant
  • AML
  • ALL
  • MDS
  • CML
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Indiana University Cancer Center Indianapolis, Indiana  46202-5265