NCT02316964

Decitabine, Donor Natural Killer Cells, and Aldesleukin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase I Study of Decitabine and Haplo-identical Natural Killer Cells in Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sumithira Vasu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot trial studies decitabine, donor natural killer cells, and aldesleukin in treating patients with acute myeloid leukemia that has come back after previous treatment (relapsed) or has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving donor natural killer cells after decitabine may boost the patient's immune system by helping it see the remaining cancer cells as not belonging in the patient's body and causing it to destroy them (called graft-versus-tumor effect). Aldesleukin may stimulate natural killer cells to kill acute myeloid leukemia cells. Giving decitabine, donor natural killer cells, and aldesleukin may be a better treatment for acute myeloid leukemia.

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility and safety of decitabine followed by natural killer (NK) cells and IL-2 (Interleukin). II. To define the specific toxicities and the dose limiting toxicity (DLT) of decitabine plus NK cells and IL-2. III. To determine the feasibility and safety of manufacturing processes for NK cells. SECONDARY OBJECTIVES: I. To determine the overall response rate (ORR). II. To determine the rate of complete remission (CR) to this regimen of decitabine plus NK cells and IL-2 (interleukin) in acute myeloid leukemia (AML). TERTIARY OBJECTIVES: I. To correlate the biological activity of decitabine as in upregulating ligands that mediate susceptibility to NK mediated cytotoxicity. II. To characterize the biological activity of infused NK cells and persistence as defined by NK chimerism. III. To evaluate if decitabine has immunosuppressive properties or modulates changes in endogenous cytokines in patients. OUTLINE: Patients receive decitabine intravenously (IV) over 60 minutes on days -4 to 0 and undergo infusion of allogeneic NK cells on day 0. Beginning 1 hour after infusion allogeneic NK cells, patients also receive aldesleukin subcutaneously (SC) every other day for 6 doses. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Del(5q)
• Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
• Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
• Recurrent Adult Acute Myeloid Leukemia
• Secondary Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	decitabine	20 mg/m2 Given IV (intravenous) for 5 days over 60 minutes
BIOLOGICAL	natural killer cell therapy	Undergo infusion of allogeneic NK cells on day 0
BIOLOGICAL	aldesleukin	Given SC
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2015-04-21
• Primary completion: 2017-12-06
• Completion: 2019-12-20
• First posted: 2014-12-15
• Last updated: 2020-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study