Promising combo for relapsed AML stalls as trial ends early
NCT ID NCT05799079
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested a combination of three oral drugs—decitabine, cedazuridine, and venetoclax—in adults whose acute myeloid leukemia (AML) came back after a donor stem cell transplant. The goal was to see if the drugs could kill cancer cells and achieve a complete remission. However, the study was terminated early after enrolling only one person, so no meaningful conclusions can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- decitabine, cedazuridine, and venetoclax
- What this could lead to
- If it worked, this combination could offer a new treatment option for AML that returns after a stem cell transplant.
- What could go wrong
- The trial was terminated early with only 1 participant, so we have very little data. It is unclear if the combination is safe or effective.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
1 person
The number who actually took part.
- Started
-
Apr 2023
- Finished
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Sep 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
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18 years and older
- Sex
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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: * Age \>= 18 years at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF and meet all study requirements * History of morphologically confirmed AML (per World Health Organization \[WHO\] diagnostic criteria) with evidence of disease recurrence (\>= 5% blasts consistent with prior disease) that occurs after allogeneic hematopoietic cell transplantation (HCT). Patients transplanted for another indication (e.g., myelodysplastic syndrome/chronic myelomonocytic leukemia \[MDS/CMML\]) who relapse with AML are eligible to enroll * White blood cells (WBC) must be less than 25,000/ul for at least three days prior to cycle 1, day 1 (C1D1) (hydroxyurea allowed) * A bone marrow biopsy must be performed and tissue collected for entrance to the trial * Eastern Cooperative Oncology Group Performance Status of 0 - 2 * Alanine transaminase (ALT) serum glutamic pyruvic transaminase (SGPT) and/or aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) less than or equal to 3x upper limit of normal (ULN) * Total bilirubin \< 1.5 x ULN \* Patients with Gilbert's syndrome (hereditary indirect hyperbilirubinemia) must have a total bilirubin of \< 3 x ULN * Calculated creatinine clearance \>= 30 ml/min (per the Cockroft-Gault formula) * Willingness to abide by all study requirements, including contraception, maintenance of a pill diary, and acceptance of recommended supportive care medications Exclusion Criteria: * Prior relapse or progression while receiving venetoclax or other commercially available or investigational BCL-2 inhibitor * Anticancer therapy, including investigational agents =\< 2 weeks or =\< 5 half-lives of the drug, whichever is shorter, prior to C1D1. (Use of hydroxyurea is permitted) * Inadequate recovery from toxicity attributed to prior anti-cancer therapy to =\< Grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version \[v\]5.0), excluding alopecia or fatigue * History of allogeneic HCT, or other cellular therapy product, within 3 months of signing consent * Clinically active acute or chronic graft versus host disease (GVHD). Patients must be off calcineurin inhibitors for at least 4 weeks to be eligible * Radiation therapy or major surgery within 3 weeks of signing consent * Active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible. Prophylaxis is acceptable * Inability to tolerate oral medication, presence of poorly controlled gastrointestinal disease, or dysfunction that could affect study drug absorption * Active documented central nervous system leukemia * Concurrent treatment with a non-permitted concomitant medication * Other malignancy IF currently being treated or likely to be treated in next 6 months except for basal or squamous cell carcinoma of the skin or cervical carcinoma in situ * Pregnancy or breastfeeding females * Known chronic alcohol or drug abuse * Clinically significant cardiovascular disease with major event or cardiac intervention within the past 6 months (e.g. percutaneous intervention, coronary artery bypass graft, documented cardiac heart failure) as determined by the investigator * Any other condition deemed by the investigator to make the patient a poor candidate for clinical trial and/or treatment with investigational agents
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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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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug combo aims to outsmart resistant leukemia
- Selective immune cell removal may tame transplant complications
- Promising combo for IDH1 leukemia hits early snag – trial stopped
- Engineered immune cells take aim at Hard-to-Treat leukemia
- New radiation method may make stem cell transplants safer for older leukemia patients
- Triple-Drug attack on tough leukemia shows promise but trial halted