Experimental drug combo takes aim at relapsed leukemia
NCT ID NCT04874480
First seen Jun 24, 2026 · Last updated Aug 26, 2026 · Updated 5 times
Summary
This early-phase trial tests a new drug called tegavivint, given together with the chemotherapy decitabine, for people whose leukemia has returned or not responded to standard treatments. The main goals are to find the safest dose and to watch for side effects. Only 9 adults with relapsed or refractory acute myeloid leukemia are taking part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tegavivint (BC-2059) combined with decitabine
- What this could lead to
- If it works, this could point toward a new treatment option for people with leukemia that has come back or stopped responding to other therapies.
- What could go wrong
- This is a very early (Phase I) trial with only 9 participants, so it is mainly looking at safety and dosing. It may not lead to an effective treatment, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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9 people
The number who actually took part.
- Started
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Sep 2021
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * 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 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 * Prior treatment with tegavivint
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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