Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-14040

Full Title

Pilot study of decitabine and haplo-identical Natural killer cells in acute myeloid leukemia


This pilot clinical 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 destroying them. 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.

Study Objective


I. To determine the feasibility and safety of decitabine followed by natural killer (NK) cells and IL-2 (aldesleukin).

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.


I. To determine the overall response rate (ORR).

II. To determine the rate of complete remission (CR) to decitabine plus NK cells and IL-2 in acute myeloid leukemia (AML).


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.


Patients receive decitabine intravenously (IV) over 60 minutes on days -4 to 0 and undergo allogeneic NK cells infusion on day 0. Beginning 1 hour after allogeneic NK cells infusion, patients also receive aldesleukin subcutaneously (SC) every other day for 6 doses.

After completion of study treatment, patients are followed up for 6 months.

Are you eligible?

Inclusion Criteria:

Patients with relapsed or refractory AML

Patients without a response after two cycles of a 10-day course of decitabine

Patients with primary refractory AML (persistent disease after standard induction with 7+3) or relapsed AML

Patients who have relapsed post-allogeneic transplant

Patients with secondary AML or therapy related disease (t-AML) are eligible; patients who received decitabine or 5-azacytidine as prior treatment for myelodysplastic syndrome (MDS) remain eligible

Patients with central nervous system (CNS) leukemia are eligible as long as they have received treatment and most recent cerebrospinal fluid (CSF) analysis is negative for leukemia

If the patient has co-morbid medical illness, life expectancy attributed to the comorbid illness must be greater than 6 months

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Total bilirubin < 2.0 mg/dL

Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal

Creatinine < 2.0 mg/dL

New York Heart Association (NYHA) congestive heart failure (CHF) class II or better

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; if the patient does not agree, the patient is not eligible; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Ability to understand and willingness to sign the written informed consent document

Human immunodeficiency virus (HIV) infection without acquired immune deficiency syndrome (AIDS)-defining criteria are eligible

DONOR: Donors must be human leukocyte antigen (HLA)-haploidentical first-degree relatives of the patient; eligible donors include biological parents, siblings or half-siblings, or children

Donor: Must be >= 18 years (yrs) old

DONOR: Donor must be in general good health and eligible for apheresis as determined by the medical provider

DONOR: HLA-haploidentical donor/recipient match by at least class I serologic typing at the HLA-A and B loci

DONOR: Willing and able to provide informed consent

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study

Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment

Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine that are not easily managed

Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; as infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control

Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study

Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women

Patients with metastatic malignant solid tumors who received treatment in the past 6 months are excluded

Known allergy to iron dextran or presence of human anti-mouse antibodies

DONOR: Pregnancy

DONOR: Positive or reactive test results for Food and Drug Administration (FDA)-mandated relevant communicable diseases (HIV, hepatitis B [hep B], hepatitis C, human T-cell lymphotropic virus [HTLV], Syphilis, Trypanosoma [T.] cruzi)