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Pilot Study of Expanded, Activated Haploidentical Natural Killer Cell Infusions for Non-B Lineage Hematologic Malignancies and Solid Tumors


Phase 1
N/A
18 Years
Open (Enrolling)
Both
Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute, T-Cell, Juvenile Myelomonocytic Leukemia Lymphoblastic, T-cell Lymphoblastic Lymphoma, Myelodysplastic Syndrome

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Trial Information

Pilot Study of Expanded, Activated Haploidentical Natural Killer Cell Infusions for Non-B Lineage Hematologic Malignancies and Solid Tumors


Secondary objectives include the evaluation of the in vivo lifespan and phenotype of the
expanded NK cells and explore the efficacy of these donor NK cells in study participants
with relapsed or refractory hematologic malignancies or sarcomas.


Inclusion Criteria:



- Less than or equal to 18 years of age (may be greater than 18 years of age if
currently a St. Jude patient).

- Patients with relapsed or refractory AML, T-ALL/T-LL, CML, JMML, MDS, ESFT or RMS who
are not eligible for SCT and have persistent disease after remission induction(s)
therapy as evidenced by bone marrow morphology, cytogenetics, flow cytometry,
molecular pathology, and/or restaging scans.

- At least two weeks since receipt of any biological therapy, systemic chemotherapy,
and/or radiation therapy.

- Shortening fraction greater than or equal to 25%.

- Glomerular filtration rate greater than or equal to 50 cc/min/1.73 m2.

- Pulse oximetry greater than or equal to 92% on room air.

- Direct bilirubin less than or equal to 3.0 mg/dL.

- Karnofsky or Lansky performance score of greater than or equal to 50.

- No known allergy to murine products or HAMA testing results within normal limits.

- Does not have a current pleural or pericardial effusion.

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

- Is not receiving more than the equivalent of prednisone 10 mg daily.

- Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days
prior to enrollment).

- Not lactating.

Eligibility criteria prior to initiation of protocol therapy (preparative regimen)

- Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal.

- Aspartate transaminase (AST) is no more than 2 times the upper limit of normal.

- Has recovered from all acute NCI Common Toxicity Criteria grade II-IV non-hematologic
acute toxicities resulting from prior therapy per the judgment of the PI

Eligibility criteria (NK cell DONOR):

- Family member with a greater than or equal to 3 of 6 HLA match to recipient.

- At least 18 years of age.

- HIV negative.

- Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days
prior to enrollment). Not lactating.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose of expanded NK cells in research participants with relapsed or refractory hematologic malignancies and sarcomas.

Outcome Time Frame:

4 Years

Safety Issue:

Yes

Principal Investigator

David Shook, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NKEXP

NCT ID:

NCT00640796

Start Date:

September 2008

Completion Date:

January 2014

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia, Lymphocytic, Acute, T-Cell
  • Juvenile Myelomonocytic Leukemia Lymphoblastic
  • T-cell Lymphoblastic Lymphoma
  • Myelodysplastic Syndrome
  • Hematologic malignancies, non-B lineage
  • NK cell expansion
  • CliniMACS device
  • Immunotherapy
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Lymphoma, Non-Hodgkin
  • Leukemia, Myelomonocytic, Juvenile
  • Hematologic Neoplasms
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

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