Imetelstat Combinations in Relapsed AML

Inclusion Criteria

• •Participants must be ≥18 years of age at time of signing the Informed Consent Form (ICF).
• •Participants must voluntarily sign an ICF.
• •Participants must have WHO-confirmed non-APL AML who have not responded to or relapsed after at least one prior therapy and for whom no standard therapy that may provide clinical benefit is available.
• •o Participants with isolated extramedullary disease (EMD), including leukemia cutis, are included but not those with active known CNS disease.
• •Participants must have a life expectancy of at least 12 weeks per investigator.
• •ECOG performance status ≤ 3.
• •Women of child bearing potential (WOCBP), defined as a sexually mature woman not surgically sterilized or post-menopausal for at least 24 consecutive months if ≤55 years or 12 months if \>55 years, must have a negative serum pregnancy test at screening and cycle 1 day 1 and must agree to use highly effective methods of birth control starting with the first dose of study therapy through 6 months after the last dose of study therapy. Highly effective methods of contraception include double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence
• •Male participants should agree to use a highly effective method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy. 8. Must have adequate organ function as demonstrated by the following:
• •* Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement or Gilbert's syndrome.
• •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.
• •* Creatinine clearance (CrCl) ≥ 30 mL/min (measured or estimated by Cockcroft-Gault formula).
• •Ability to adhere to the study visit schedule and all protocol requirements.
• •Ability to understand and the willingness to sign a written informed consent.
• •Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the participant from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• •Known history of uncontrolled human immunodeficiency virus (HIV)
• •Active known systemic hepatitis A, B, or C infection requiring therapy or known cirrhosis.
• •Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or pharmaceutical sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific participant.
• •Organ transplant recipients other than bone marrow transplant.
• •Women who are pregnant or lactating.