AML - Acute Myeloid LeukemiaPhase 1DLIT-AMLNCT07014462
A Phase 1B Investigator Initiated Study of Safety and Tolerability of Dexamethasone (D) in Combination With Venetoclax-based Low-Intensity Therapy (LIT) in Treatment-Naïve Acute Myeloid Leukemia (AML): DLIT-AML
A Phase 1 study testing Dexamethasone plus Venetoclax-based Low-Intensity Therapy in people with AML - Acute Myeloid Leukemia, run by University of Vermont at 1 site in United States.
Trial summary
This study is investigating whether adding dexamethasone, an anti-inflammatory medication, to a standard venetoclax-based low-intensity therapy (LIT) is safe and well-tolerated in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are not eligible for intensive chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML - Acute Myeloid Leukemia
- What is being tested?
- Dexamethasone plus Venetoclax-based Low-Intensity Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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:
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
This study is investigating whether adding dexamethasone, an anti-inflammatory medication, to a standard venetoclax-based low-intensity therapy (LIT) is safe and well-tolerated in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are not eligible for intensive chemotherapy.
Study Goals Primary Goal: To assess the safety and tolerability of dexamethasone in combination with venetoclax-based LIT.
Read more
Secondary Goal: To evaluate how this treatment affects patients' quality of life using surveys.
Exploratory Goal: To measure the treatment response, including remission rates and signs of minimal residual disease.
What Happens in the Study? Patients will receive treatment over six cycles. Dexamethasone is given in different doses during the first six cycles along with venetoclax and another standard chemotherapy drug.
- Conditions
- AML - Acute Myeloid Leukemia
- Being tested
- Dexamethasone plus Venetoclax-based Low-Intensity Therapy
- Keywords
- AML, Dexamethasone, Venetoclax-
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone plus Venetoclax-based Low-Intensity TherapyDrug
Participants will receive standard low-intensity therapy (LIT) regimens for newly diagnosed AML, which may include venetoclax combined with either azacitidine, decitabine, or low-dose cytarabine, per treating physician's discretion. In addition, participants will receive dexamethasone administered orally at 10 mg twice daily on days 1-3 of cycles 1 and 2, and 20 mg orally on day 1 of cycles 3 through 6. This intervention is being studied to evaluate whether the addition of dexamethasone improves tolerability and clinical outcomes in patients unfit for intensive chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Adults with ND-AML | Experimental | This is a single-arm, phase 1b, investigator-initiated study evaluating the safety and tolerability of adding dexamethasone to standard venetoclax-based low-intensity therapy (LIT) regimens in treatment-naïve adult patients with acute myeloid leukemia (AML) who are unfit for intensive chemotherapy induction. Participants will receive venetoclax in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine, per treating physician's choice. Dexamethasone will be administered orally at 10 mg twice daily on days 1-3 of cycles 1 and 2, and 20 mg once on day 1 of cycles 3 through 6. Treatment will continue for up to 6 cycles (28 days each). The study also includes assessments of patient-reported outcomes and exploratory efficacy endpoints. Receives: Drug: Dexamethasone plus Venetoclax-based Low-Intensity Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of adding dexamethasone to venetoclax-based low-intensity therapy in treatment-naïve AML patients
The primary outcome will assess the safety and tolerability of the combined regimen. This will include the incidence and severity of adverse events (AEs) graded by NCI CTCAE v5.0, with special attention to clinically significant non-hematologic grade 4 AEs during the first 2 cycles. Overall AE frequency, organ system affected, and hematologic vs. non-hematologic classification will be recorded. Short-term toxicity will be reviewed after enrollment of the first 8-10 patients to determine feasibility for continued accrual.
Measured: From start of treatment through completion of 6 cycles (each cycle is 28 days; approximately 6 months total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Sep 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML - Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Adrianzen Herrera, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014462
- Sponsor's protocol ID
- STUDY00003614/UVMC2503
- Acronym
- DLIT-AML
- Status last verified
- Sep 2025
- First submitted
- 6 May 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Investigator Initiated Study of Safety and Tolerability of Dexamethasone (D) in Combination With Venetoclax-based Low-Intensity Therapy (LIT) in Treatment-Naïve Acute Myeloid Leukemia (AML): DLIT-AML
- ClinicalTrials.gov ID
- NCT07014462
- Acronym / sponsor ID
- DLIT-AML / STUDY00003614/UVMC2503
- Conditions
- AML - Acute Myeloid Leukemia
- Keywords
- AML, Dexamethasone, Venetoclax-
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is investigating whether adding dexamethasone, an anti-inflammatory medication, to a standard venetoclax-based low-intensity therapy (LIT) is safe and well-tolerated in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are not eligible for intensive chemotherapy.
Study Goals Primary Goal: To assess the safety and tolerability of dexamethasone in combination with venetoclax-based LIT.
Secondary Goal: To evaluate how this treatment affects patients' quality of life using surveys.
Exploratory Goal: To measure the treatment response, including remission rates and signs of minimal residual disease.
What Happens in the Study? Patients will receive treatment over six cycles. Dexamethasone is given in different doses during the first six cycles along with venetoclax and another standard chemotherapy drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with ND-AML | Experimental | Drug: Dexamethasone plus Venetoclax-based Low-Intensity TherapyThis is a single-arm, phase 1b, investigator-initiated study evaluating the safety and tolerability of adding dexamethasone to standard venetoclax-based low-intensity therapy (LIT) regimens in treatment-naïve adult patients with acute myeloid leukemia (AML) who are unfit for intensive chemotherapy induction. Participants will receive venetoclax in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine, per treating physician's choice. Dexamethasone will be administered orally at 10 mg twice daily on days 1-3 of cycles 1 and 2, and 20 mg once on day 1 of cycles 3 through 6. Treatment will continue for up to 6 cycles (28 days each). The study also includes assessments of patient-reported outcomes and exploratory efficacy endpoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone plus Venetoclax-based Low-Intensity TherapyParticipants will receive standard low-intensity therapy (LIT) regimens for newly diagnosed AML, which may include venetoclax combined with either azacitidine, decitabine, or low-dose cytarabine, per treating physician's discretion. In addition, participants will receive dexamethasone administered orally at 10 mg twice daily on days 1-3 of cycles 1 and 2, and 20 mg orally on day 1 of cycles 3 through 6. This intervention is being studied to evaluate whether the addition of dexamethasone improves tolerability and clinical outcomes in patients unfit for intensive chemotherapy. | Drug | Adults with ND-AML |
Primary outcome
Safety and tolerability of adding dexamethasone to venetoclax-based low-intensity therapy in treatment-naïve AML patients
Time frame: From start of treatment through completion of 6 cycles (each cycle is 28 days; approximately 6 months total)
The primary outcome will assess the safety and tolerability of the combined regimen. This will include the incidence and severity of adverse events (AEs) graded by NCI CTCAE v5.0, with special attention to clinically significant non-hematologic grade 4 AEs during the first 2 cycles. Overall AE frequency, organ system affected, and hematologic vs. non-hematologic classification will be recorded. Short-term toxicity will be reviewed after enrollment of the first 8-10 patients to determine feasibility for continued accrual.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No. Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone plus Venetoclax-based Low-Intensity Therapy in people with AML - Acute Myeloid Leukemia, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of adding dexamethasone to venetoclax-based low-intensity therapy in treatment-naïve AML patients (time frame: From start of treatment through completion of 6 cycles (each cycle is 28 days; approximately 6 months total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.