Can a common drug boost Chemo's power against Hard-to-Treat leukemia?
NCT ID NCT07766850
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial is testing whether adding hydroxyurea to a standard chemotherapy combination can improve outcomes for adults with acute myeloid leukemia (AML) that has returned or not responded to treatment. The study is conducted in two parts: first to find the safest dose of hydroxyurea, then to see if it helps keep the disease from progressing. Participants receive hydroxyurea alongside fludarabine, cytarabine, idarubicin, and venetoclax, with the goal of improving event-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hydroxyurea added to a combination of fludarabine, cytarabine, idarubicin, and venetoclax
- What this could lead to
- If successful, this could offer a new, more effective treatment option for adults with AML that has returned or not responded to prior therapy, potentially extending the time without disease progression.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not hold in larger groups. Adding hydroxyurea could increase side effects, and the benefit over standard treatment is not yet proven.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2034
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 to 74 years
- 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: 1. A diagnosis of either: * Refractory AML defined as having \> 10% bone marrow blasts after induction with one cycle of intensive chemotherapy or no CR after two cycles of chemotherapy. * Relapsed disease (including extramedullary disease) according to the 2022 ELN criteria (see appendix A). * MRD relapse defined as evidence of measurable (minimal) residual disease (MRD) at a level of ≥5%, as determined by either molecular assays or multiparameter flow cytometry. 2. Age 18 years or older. 3. ECOG Performance Status ≤ 2. 4. Adequate renal and hepatic functions as indicated by the following laboratory values: * Creatinine clearance ≥ 30 mL/min calculated by the Cockcroft Gault formula. * Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless due to Gilbert's syndrome. * Alanine aminotransferase (ALAT) ≤ 5 x ULN. 5. Considered fit for intensive chemotherapy. 6. Male patients must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid fathering a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control. 7. Male patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration. 8. Female patients of nonchildbearing potential must be postmenopausal (defined as at least 1 year without any menses), documented surgically sterile prior to screening. 9. Female patients of childbearing potential must agree to avoid pregnancy during the study and for 6 months after the final study drug administration and have a negative urine or serum pregnancy test at screening, and if heterosexually active, agree to consistently apply one highly effective method of birth control in combination to a barrier method for the duration of the study and for 6 months after the final study drug administration. 10. The subject has given their written consent to participate in the trial. 11. Patient is capable of giving informed consent. Exclusion Criteria: 1. Acute promyelocytic leukemia. 2. WBC ≥30; pretreatment with HU to reduce the level of WBC \<30 is allowed in part B/phase II of the trial. 3. TP53 double hit mutation / biallelic TP53 inactivation. 4. CNS leukemia. 5. Relapse within 3 months from the date of allo-HCT. 6. Uncontrolled infection. 7. ECOG Performance Status \> 2. 8. Major organ failure precluding administration of planned chemotherapy 9. Cardiac dysfunction as defined by: * Myocardial infarction within the last 3 months of study entry, or * Reduced left ventricular function with an ejection fraction \< 50% as measured by echocardiogram (will only be performed when clinically suspected) or * Unstable angina or * New York Heart Association (NYHA) grade III or IV congestive heart failure (see appendix C) or * Severe cardiac arrhythmias 10. Age 75 years or older. 11. Known intolerance to any of the chemotherapeutic drugs in the protocol. 12. Positive pregnancy test. 13. Lactating female or female of childbearing potential not using adequate contraception. 14. Known inherited bone marrow failure syndromes (e.g., Fanconi anemia, Dyskeratosis congenita and related telomeropathies (e.g., TERT, TERC, DKC1 mutations). 15. Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medical Unit Hematology, Karolinska University Hospital
Stockholm, Sweden
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