Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase Ib/II trial finds out the best dose and effect of cladribine and low dose cytarabine when given in combination with uproleselan in treating patients with treated secondary acute myeloid leukemia. Chemotherapy drugs, such as uproleselan, 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: 2-chloro-3'-deoxyadenosine; Cladribine; Cytarabine

Criteria

Inclusion Criteria:

• Patients with a diagnosis of treated secondary-AML (TS-AML) who have not received therapy for their AML will be eligible

• TS-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm)

• Age >= 18 years

• Total bilirubin =< 2mg/dL

• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) - or < 5 x ULN if related to leukemic involvement

• Creatinine =< 1.5 x ULN

• Known cardiac ejection fraction of > or = 45% within the past 6 months

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

• A negative urine or serum 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 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 active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Patients 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 treatment with uproleselan

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