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Pilot Study of Haploidentical Natural Killer Cell Infusions for Poor Prognosis Non-AML Hematologic Malignancies


Phase 1
N/A
18 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma

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Trial Information

Pilot Study of Haploidentical Natural Killer Cell Infusions for Poor Prognosis Non-AML Hematologic Malignancies


This study will evaluate the persistence, phenotype and function of donor NK cells as well
as exploring the efficacy of the infusion in research participants with chemotherapy
refractory hematologic malignancies.


Inclusion Criteria:



- At least two weeks since receipt of last biological therapy, chemotherapy, or
radiation therapy.

- Has a suitable adult family member donor available for NK cell donation.

- No current pleural or pericardial effusion.

- HIV negative

- Adequate clinical standing as evidenced by being within multiple renal, hepatic,
pulmonary, and neurological required testing parameters.

Exclusion Criteria:

- Pregnant or lactating

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety of chemotherapy and IL-2 administration to facilitate transient NK-cell engraftment in research participants with chemotherapy refractory non-acute myelogenous leukemia (non-AML) hematologic malignancies

Outcome Time Frame:

4 months post infusion

Safety Issue:

Yes

Principal Investigator

Wing Leung, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NKHEM

NCT ID:

NCT00697671

Start Date:

March 2007

Completion Date:

May 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Juvenile Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Non-Hodgkin's Lymphoma
  • NK cell infusion
  • Immunotherapy
  • hematologic malignancy
  • Miltenyi Biotec device
  • haploidentical donor
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Juvenile
  • Hematologic Neoplasms

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794