Could a common steroid make AML treatment easier to tolerate?
NCT ID NCT07014462
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests whether adding the steroid dexamethasone to standard low-intensity chemotherapy is safe and tolerable for adults newly diagnosed with acute myeloid leukemia (AML) who cannot have intensive chemo. About 20 participants will receive the combination over six cycles, with close monitoring for side effects and quality of life. The goal is to see if this approach can reduce treatment-related toxicity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexamethasone plus venetoclax-based low-intensity therapy (azacitidine, decitabine, or low-dose cytarabine)
- What this could lead to
- If it works, this could point toward a more tolerable treatment option for AML patients who cannot handle intensive chemotherapy.
- What could go wrong
- This is a very early phase 1 trial with only 20 participants, so it is primarily checking safety, not effectiveness. The added dexamethasone may cause 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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jun 2029
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: Age ≥ 18 years ECOG performance status ≤2 Newly diagnosed AML morphologically confirmed in a bone marrow biopsy and aspiration done within 2 months of study enrollment, following the WHO 2022 morphologic classification for myeloid malignancies9 No prior AML treatment (treatment-naïve) Ineligibility or unwillingness to undergo high-dose chemotherapy induction. Patient candidacy for high dose intensive chemotherapy or ineligibility due to older age or unfit medical status will be determined by the primary treating physician. Adequate renal function including creatinine clearance \> 30 ml/min based on the Cockcroft-Gault equation Normal liver function with direct bilirubin ≤ 2xULN, ALT and AST ≤ 3xULN, unless deemed to be related to underlying leukemia Women of child-bearing potential and men (except if previous vasectomy) must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Ability to understand and the willingness to sign a written informed consent. Patients with known previous exposure to HMA or LDAC for treatment of a pre-leukemic condition including myelodysplastic syndromes or myeloproliferative neoplasms are eligible. Exclusion Acute promyelocytic leukemia diagnosis Bone marrow transplant expected after first or second cycle of venetoclax-based LIT. White Blood Cell (WBC) count \>25K. If WBC is \>25K in an otherwise eligible patient, the use of cytoreduction is allowed and patients can be included when WBC \<25K. Hydroxyurea (at any dose) and/or one dose of cytarabine (up to 2 g/m2) for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions: 1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia, or 2) cytoreduction as point 3.2.3. Uncontrollable infectious disease within 7 days of study enrollment defined as infection confirmed on laboratory tests or imaging and associated with systemic inflammatory response syndrome (SIRS), circulatory compromise or respiratory failure, where steroid treatment may be detrimental according to investigator. Clinically stable febrile neutropenia attributable to AML is not an exclusion criteria. Patients with any concurrent uncontrolled clinically significant medical condition, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment. Baseline high-dose steroid treatment at dose preceding AML diagnosis for any cause, including concomitant autoimmune disease. The maximum acceptable daily steroid dose is the equivalent of 5 mg of prednisone. Adrenal insufficiency Active peptic ulcer disease (PUD), defined as actively having severe pain requiring intervention or bleeding. A simple history of PUD is not an exclusion criterion. If a patient with history of PUD is enrolled, proton pump inhibitor prophylaxis will be used. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known uncontrolled HIV infection. Patients with a history of treated HBV or HCV which has been previously treated, or those with controlled HIV on treatment are eligible. Patients receiving any other investigational agents Pregnant or nursing patients Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications Patients with uncontrolled diabetes, defined as hemoglobin A1C (HgbA1C) levels \>9 and significant baseline hyperglycemia. Patients with controlled diabetes are eligible provided they continue with their treatments and HgbA1C is monitored every 3 months. HgbA1C levels are required only in diabetic patients riteria: \-
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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University of Vermont Medical Center
Burlington, Vermont, 05401, United States
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