TK216 and Decitabine in Treating Patients With Relapsed and Refractory Acute Myeloid Leukemia

• Status: Withdrawn
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial studies the side effects and best dose of TK216 and decitabine when given together in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as TK216 and decitabine, 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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Azacitidine; Decitabine

Criteria

Inclusion Criteria:

• Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia for which no available standard therapies are indicated or anticipated to result in a durable response

• Patients must not have had leukemia therapy for 14 days prior to starting TK216. However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and during the first cycle of study

• Bilirubin =< 2 mg/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 3 months

• 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 agent used in this study has 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

• Patient with documented hypersensitivity to any of the components of the therapy program

• Patients with active, uncontrolled central nervous system (CNS) leukemia will not be eligible

• Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use at least 1 form of barrier birth control (such as condom) prior to study entry and for the duration of study participation

• Patients with known history of serous retinopathy will not be eligible

• Prior treatment with TK216