Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2022-01-03
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well venetoclax, cladribine, low dose cytarabine, and azacitidine work in treating patients with acute myeloid leukemia that has previously not been treated. Drugs used in chemotherapy, such as venetoclax, cladribine, and low dose cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax, cladribine, low dose cytarabine induction followed by cladribine, low dose cytarabine, and azacitidine consolidation may work better in treating patients with acute myeloid leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: 2-chloro-3'-deoxyadenosine; Azacitidine; Cladribine; Cytarabine; Venetoclax

Criteria

Inclusion Criteria:

• Patients with previously untreated acute myeloid leukemia (AML). Prior therapy with hydroxyurea, hematopoietic growth factors, HMA, all-trans retinoic acid (ATRA), or a total dose of cytarabine up to 2 g (for emergency use for stabilization) is allowed.

• Patients aged < 50 years who are unsuitable for standard induction therapy may be eligible after discussion with primary investigator.

• Bilirubin =< 2 mg/dL. Unless liver enzyme abnormalities are determined by the treating Doctor of Medicine (MD) and principal investigator (PI) to be due to leukemic infiltration.

• Aspartate aminotransferase (AST) and/or alanine aminotransferase (AL)T =< 3 x ULN. Unless liver enzyme abnormalities are determined by the treating MD and PI to be due to leukemic infiltration.

• Creatinine =< 1.5 x upper limit of normal (ULN).

• Eastern Cooperative Oncology Group (ECOG) performance status of =< 2.

• A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.

• Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.

Exclusion Criteria:

• Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.

• Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Patient with documented hypersensitivity to any of the components of the chemotherapy program.

• Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.

• Prior therapy with venetoclax.

• Patients with a diagnosis of acute promyelocytic leukemia (AML-M3) will be excluded from this study.