NCT01898793

Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

A Phase 1/2 Study of Cytokine-Induced Memory-Like NK Cells in Patients With AML or MDS

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This phase I/2 trial studies the side effects and best dose of activated natural killer cells in treating patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes. Giving chemotherapy before a donor natural killer cell infusion helps stop the growth of cancer cells and stops the patient's immune system from rejecting the donor's natural killer cells. Modified natural killer cells may help the body build an immune response to kill cancer cells. Aldesleukin (interleukin-2) may stimulate the white blood cells (including natural killer cells) to kill leukemia cells. In the phase II and pediatric portion of the study, the investigators intend to use maximal tolerated or tested (MT/TD) CIML NK cell dose as determined from the phase I part of this study. The phase II portion of the study also replaces IL-2 with ALT-803. The rationale for this change is to support the donor derived NK cells in vivo after adoptive transfer. With amendment 16, the decision was made to return to the use of rhIL-2 support instead of ALT-803.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	Fludarabine
DRUG	Cyclophosphamide
PROCEDURE	Leukapheresis
BIOLOGICAL	Cytokine-induced killer cells
BIOLOGICAL	IL-2
DRUG	ALT-803
PROCEDURE	Peripheral blood for correlative studies	-Screening, Day 0 prior to CIML NK infusion, Day 1, Day 3, Day 7, Day 8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 60, Day 100, 6 months, 9 months, 12 months, and at disease relapse
PROCEDURE	Bone marrow for correlative studies	-Screening, Day 8, Day 14, Day 28, Between Day 42 and 60, Day 100, at disease relapse

Timeline

• Start date: 2014-08-11
• Primary completion: 2021-12-28
• Completion: 2022-04-04
• First posted: 2013-07-12
• Last updated: 2024-01-17
• Results posted: 2023-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study