Off-the-shelf Third Party Expanded NK Cells in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial studies the side effects of donor natural killer (NK) cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory), or myelodysplastic syndrome. Natural killer cells are a type of immune cell. Immunotherapy with genetically modified NK cells from donors may induce changes in the body?s immune system and may interfere with the ability of cancer cells to grow and spread.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sumithira Vasu
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cytarabine; Decitabine; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

• Patients with one of the following diagnoses:

• Relapsed or primary refractory acute myeloid leukemia (AML), including

• Patients with relapsed AML after allogeneic stem cells transplantation, including those who have received donor lymphocyte infusions

• Isolated central nervous system (CNS) or extramedullary disease

• Note: a response monitoring plan must be developed a priori for subjects with extramedullary disease

• Myelodysplastic syndrome

• >= 10% blasts, including patients who have received prior hypomethylating agents

• Karnofsky or Lansky performance scale (PS) greater or equal to 70

• Serum creatinine =< 2 mg/dl or creatinine clearance greater or equal than 40 cc/min. Creatinine for pediatric patients =< 2 mg/dl or =< 2 times upper limit of normal for age (whichever is less)

• Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of expected, corrected for hemoglobin. For pediatric patients, if unable to perform pulmonary function tests (most children < 7 years of age), pulse oximetry >= 92% on room air by pulse oximetry

• Total bilirubin =< 2 mg/dl or =< 2.5 x upper limit or normal (ULN) for age (unless Gilbert's syndrome)

• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN for age

• Left ventricular ejection fraction >= 40%

• Patients with seizure disorder may be eligible if seizures well controlled

• Negative serum test to rule out pregnancy within 2 weeks prior to enrollment in females of childbearing potential (non-childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized)

• Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator

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

• Negative serology for human immunodeficiency virus (HIV)

Exclusion Criteria:

• Investigational therapies in the 2 weeks prior to beginning treatment on this protocol

• Any comorbidities that in the opinion of the investigator will preclude receiving fludarabine, decitabine or cytarabine

• Uncontrolled infection, defined as an infection which has not resolved spontaneously or does not show evidence of significant resolution after initiating appropriate therapy. Asymptomatic viremia such as cytomegalovirus (CMV), human papillomavirus (HPV), BK virus, hepatitis C virus (HCV), etc. is NOT considered as an exclusion criteria

• Uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease

• Active graft versus host disease (GVHD)

• Patient on corticosteroids to control GvHD