New combo therapy shows promise for hard-to-treat leukemia
NCT ID NCT04848974
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested whether adding the drug uproleselan to standard chemotherapy (cladribine and low-dose cytarabine) could help people with treated secondary acute myeloid leukemia (AML). Secondary AML is a type of leukemia that develops after treatment for another bone marrow disease. The study enrolled 37 adults and aimed to find the best dose and measure how many patients achieved remission. The goal is to improve outcomes for this difficult-to-treat cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- uproleselan, cladribine, and low-dose cytarabine
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with secondary AML that has returned after prior therapy.
- What could go wrong
- This is an early-phase trial with only 37 participants, so results may not apply to all patients. The added drug may also increase side effects without improving outcomes.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
37 people
The number who actually took part.
- Started
-
Jun 2021
- Finished
-
Oct 2024
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Patients with a diagnosis of treated secondary-AML (TS-AML) who have not received therapy for their AML will be eligible. 2. TS-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm that has been previously treated with hypomethylating agents). 3. Patients must be at least 7 days from their last therapy for the antecedent myeloid neoplasm 4. Age \>/= 18 years. 5. Adequate organ function as defined below: * liver function (total bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN - or \<5 x ULN if related to leukemic involvement) * kidney function (creatinine \< 1.5 x ULN ). * known cardiac ejection fraction of \> or = 45% within the past 6 months 6. ECOG performance status of ≤ 2. 7. A negative urine or serum pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 8. Patient must have the ability to understand the requirements of the study and informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol. Exclusion Criteria: 1. 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. 2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 3. Patients with documented hypersensitivity to any of the components of the chemotherapy program. 4. 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. 5. Prior treatment with uproleselan. 6. Patients with a diagnosis of acute promyelocytic leukemia (AML-M3) will be excluded from this study.
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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
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
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