Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Patients, or their legally acceptable representatives, must be willing and able to
understand and provide signed informed consent for the study that fulfills
Institution Review Board (IRB) guidelines
2. Male or female patients > 18 years of age on the day of signing informed consent
3. Subjects must have a diagnosis of AML according to the WHO criteria
(primary/de novo or secondary, including treatment-related [e.g., due to prior
anthracycline use], as well as cases due to progression of antecedent
hematological disorder [e.g., MDS, MPN, or MDS/MPN ‘overlap’ syndrome).
4. Subjects must be in second morphological complete remission (with or without
platelet recovery; CR2/CRp2) for relapsed AML based on the CRp criteria as
follows:
a. <5% myeloblasts in bone marrow.
b. Absence of Auer rods
c. Absence of circulating peripheral blasts.
d. Peripheral blood absolute neutrophil count (ANC) >1000 cells/μL.
e. Peripheral blood platelet count >60,000/μL
f. Absence of extramedullary disease.
5. Patients must have > 800 lymphocytes/ μL.
6. Patients’ leukemic blasts must express WT1 per IRS scoring system (See
APPENDIX 1: WT1 IHC Assessment and Documentation)
7. Subjects must be free of any requirement for red blood cell transfusions.
8. Subjects must not be candidates at the time of study entry for allogeneic stem cell
transplant (Allo-SCT) due to intercurrent medical conditions or lack of an
available donor.
9. Subjects must have received the last dose of induction antileukemic therapy at
least 3 months prior to study enrolment.
10. Subjects must be consented within 4 months of having achieved CR2/CRp2
11. Subjects must have an Eastern Cooperative Oncology Group (ECOG)
performance status of 0,1 or 2 (See APPENDIX 2: ECOG Performance Status)
12. Subjects must have an estimated life expectancy >6 months.
13. If female, is postmenopausal (at least 12 sequential months of amenorrhea) or
surgically sterile. Females of childbearing potential must have a negative
pregnancy test
14. Female patients of childbearing potential who are heterosexually active and male
patients with female sexual partners of childbearing potential must agree to use
an effective method of contraception (e.g., oral contraceptives, double-barrier
methods such as a condom and a diaphragm, intrauterine device) during the study
and for 4 months following the last dose of study medication, or to abstain from
sexual intercourse for this time; a woman not of childbearing potential is one who
has undergone bilateral oophorectomies or who is post- menopausal, defined as
the absence of menstrual periods for 12 consecutive months.
15. Subjects must have recovered to National Cancer Institute Common
Terminology Criteria for Adverse Events (CTCAE) v5 Grade 0 or 1 after
completion of prior AML therapy with the exception of the platelet count
requirements (i.e., as long as peripheral blood platelet count is >60,000/μL).
16. Subjects must have adequate renal function defined as a serum creatinine <2 ×
upper limit of normal (ULN) or calculated creatinine clearance > 30 mL/min
based on the Cockroft-Gault equation.
17. Subjects must have adequate hepatic function defined as a serum total bilirubin
<2 × ULN (except for Gilbert’s syndrome, which will allow bilirubin ≤3.0
mg/dL), and alanine aminotransferase (ALT) and aspartate aminotransferase
(AST) ≤3 × ULN.
18. Subjects must be willing and able to return to the clinical site for adequate followup
and to comply with the protocol as required.