Status:
ACTIVE_NOT_RECRUITING
Tegavivint for the Treatment of Relapsed or Refractory Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Recurrent Leukemia
Refractory Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is to find out the best dose and side effects of tegavivint in treating patients with leukemia that has come back (relapsed) or does not response to treatment (refractory). Tegavivi...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of tegavivint in patients with relapsed and refractory acute myeloid leukemia (AML). (Phase I d...
Eligibility Criteria
Inclusion
- 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
- Age \>= 18 years
- Patients must not have had leukemia therapy for 14 days prior to starting tegavivint (BC-2059). 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 =\< 2.5 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
- 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
- Prior treatment with tegavivint
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2027
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04874480
Start Date
September 27 2021
End Date
February 2 2027
Last Update
January 9 2026
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030