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Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia


N/A
N/A
21 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia


Natural killer (NK) cells extracted from a [parental] donor are infused intravenously. Most
patients are given a multi-agent chemotherapeutic conditioning regimen prior to the
infusion. The conditioning regimen may be omitted for patients who have previously received
traditional stem cell transplant.

Details of Treatment Plan:

Stratum 1 (AML in complete remission)

Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor
pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification
and infusion on Day 0

Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual
disease)

Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2
Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1,
and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.

For patients who have received prior SCT, the conditioning regimen may be omitted if the NK
cells are obtained from the original SCT donor.

Cytokine regimen (stratum 1 and 2): 1 million units/m2 of IL-2 given subcutaneously three
times per week for two weeks (6 doses) starting on the evening of day -1.

NK Cell Transplantation (stratum 1 and 2): NK cells from haplo-identical family donor will
be infused on day 0.


Inclusion Criteria:



- Participants with AML that is in complete remission, is relapsed or refractory, or
with increasing minimal residual disease.

- Participants in complete remission must have recovered from toxicity of previous
therapy and have evidence of bone marrow recovery

- Participants who had prior stem cell transplant (SCT) must have no evidence of GVHD
and 60 or more days have elapsed since the SCT.

Exclusion Criteria:

- Participants who are pregnant

- Participants with inadequate renal, liver, or pulmonary functions

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant

Outcome Description:

Document the number of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.

Outcome Time Frame:

Beginning at on therapy through 100 days post-transplant

Safety Issue:

Yes

Principal Investigator

Jeffrey E. Rubnitz, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Resarch Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NKAML

NCT ID:

NCT00187096

Start Date:

September 2005

Completion Date:

October 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Myeloid
  • Acute
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

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