Know Cancer

forgot password

Phase I Study of Adoptive Immunotherapy Using the Natural Killer Cell Line, ZRx-101 (NK-92), for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia

Phase 1
18 Years
Not Enrolling
Acute Myeloid Leukemia

Thank you

Trial Information

Phase I Study of Adoptive Immunotherapy Using the Natural Killer Cell Line, ZRx-101 (NK-92), for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia

Inclusion Criteria:

- Patients with acute myeloid leukemia that progressed or relapsed after two regimens
of therapy. Patients must not have received radiotherapy, chemotherapy (with the
exception of hydroxyurea which must be discontinued 72 hours prior to therapy) or
biological therapy within the preceding 2 weeks and must have recovered from any
adverse events due to prior administered agents

- Assessable disease as measured by laboratory and bone marrow examinations

- Age: Eighteen years or older

- Performance status: ECOG ≤ 2 (Appendix A)

- Serum creatinine ≤ 1.5 mg/ml and calculated creatinine clearance ≥ 50 mL/min
(using the Cockcroft-Gault equation CL creatinine = ((140-age) x body mass X 0.85 if
female)/72 x creatinine where age is given in years,body mass is given in Kg and
creatinine is given in mg/dL)

- Aspartate aminotransferase (AST) ≤ 59 IU/L

- Alanine aminotransferase (ALT) ≤ 72 IU/L

- Total bilirubin ≤ 1.3 mg/ml

- Patients must have left ventricular ejection fraction (LVEF) ≥50 %

- Females of child-bearing potential must have a negative pregnancy test and all
subjects must agree to use an effective method of contraception

- Ability to give informed consent

- Life expectancy of greater than 3 months Note: as many of eligible patients will be
pancytopenic secondary to their disease, hematologic abnormalities we will not be
used as a criteria for entry or exclusion.

Exclusion Criteria:

- Patients with acute promyelocytic leukemia

- Symptomatic central nervous system (CNS) involvement

- History of congestive heart failure

- Myocardial infarction in the past 6 months

- Uncontrolled, life-threatening infection that is not responding to antimicrobial

- Concurrent treatment with corticosteroids and/or other immunosuppressive drugs

- ECOG performance status >2 (Appendix A)

- Hepatitis B or C or HIV positive serology

- History of psychiatric disorder which may compromise compliance with the protocol or
which does not allow for appropriate informed consent

- Patient may not be receiving any other investigational agents

- PT INR> 1.5 or patient is receiving systemic anticoagulation (e.g., warfarin)

- Patient undergone autologous or allogeneic stem cell transplantation

- History of another primary cancer except for curatively treated in situ cervical
cancer and curatively resected non-melanoma skin cancer

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety / maximum tolerated dose of the ZRx-101 cell line in patients with refractory or relapsed acute myeloid leukemia

Outcome Time Frame:


Safety Issue:


Principal Investigator

Michael Boyiadzis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:

UPCI 06-118



Start Date:

September 2009

Completion Date:

June 2011

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • ZRx101
  • Refractory
  • Refractory or Relapsed Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



UPMC Cancer Center - Hillman Cancer Center Pittsburgh, Pennsylvania  15232