Natural Killer (NK) Cell Transplantation for AML

St. Jude Children's Research Hospital

Status: Completed

Conditions: Acute Myeloid Leukemia

Treatments: Device: CliniMACS System; Procedure: Natural Killer Cell Infusion; Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2

Study type: Interventional

Funder types: Other

Identifiers

NCT00187096

NKAML

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of infusing natural killer cells from a donor as treatment for patients with acute myeloid leukemia in remission or who have experienced relapse.

Full description

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.

Enrollment: 49 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Stratum 1

Experimental group

Description:

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

Treatment:

Device: CliniMACS System

Procedure: Natural Killer Cell Infusion

Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2

Stratum 2

Experimental group

Description:

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.

Treatment:

Device: CliniMACS System

Procedure: Natural Killer Cell Infusion

Drug: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2