Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ImmunityBio, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with refractory/relapse acute myeloid leukemia. 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 of the planned first Neukoplast™ cell infusion 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 \< 2 X upper limit of normal
Aspartate aminotransferase (AST) \< 5 X upper limit of normal
Alanine aminotransferase (ALT) \< 5 X upper limit of normal
Total bilirubin \< 3X upper limit of normal
Activated partial thromboplastin time (PTT) \< 2.5 X upper limit of normal
Patients must have left ventricular ejection fraction (LVEF) ≥45 %
Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of Neukoplast™
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 or prior therapies hematologic abnormalities will not be used as a criteria for entry or exclusion.
You may not be if
Patients with acute promyelocytic leukemia
Symptomatic central nervous system (CNS) involvement
History of congestive heart failure
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease).
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
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
Patient is receiving systemic anticoagulation (e.g., warfarin, intravenous heparin. Low dose prophylactic anticoagulation is allowed )
Patient undergone autologous or allogeneic stem cell transplantation
Concurrent malignancy of solid tumors. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled.
