Could a Three-Pronged attack keep High-Risk leukemia at bay?
NCT ID NCT06158100
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This phase 1 trial is testing whether a combination of two drugs (venetoclax and azacitidine) followed by donor immune cell infusions can prevent relapse in people with very high-risk acute myeloid leukemia (AML) who have already received a stem cell transplant. The study enrolls adults aged 18 to 75 whose AML is in remission but who still have a high chance of the cancer coming back. The main goals are to find the safest dose and to see if the treatment is well tolerated.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax, azacitidine, and donor lymphocyte infusion
- What this could lead to
- If successful, this combination could help prevent AML from returning after a stem cell transplant, potentially improving long-term survival for very high-risk patients.
- What could go wrong
- This is a very early phase 1 study with only a small number of participants, so safety and effectiveness are not yet established. The combination may cause significant side effects, and it is unknown whether it will actually reduce relapse rates.
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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2 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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Jun 2026
- 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 to 75 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. Male and female patients between the ages of 18-75. 2. Patients with a histologic diagnosis of AML in morphological remission (\<5% bone marrow (BM) blasts) prior to allogeneic hematopoietic cell transplantation and very high-risk for relapse defined as: (i) Presence of measurable residual disease (MRD) by multicolor flow cytometry (MFC) prior to transplant and receiving a reduced intensity conditioning (RIC) or nonmyeloablative (NMA) regimen (ii) Presence of MRD by MFC at day +30 post-transplant (iii) All patients with monosomal karyotype (MK) and those with 17p/tumor protein p53 (TP53) mutated disease irrespective of MRD status and intensity of conditioning regimen. 3. Adequate hematopoietic recovery after HCT, defined as: * Absolute neutrophil count (ANC) \>= 1 x 10\^9/L without daily use of myeloid growth factors * Platelet count \>= 50 x 10\^9/L without platelet transfusion within 1 week 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 5. Serum creatinine =\< 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min 6. Serum bilirubin =\< 1.5 x upper limit of normal (ULN) 7. Aspartate transaminase (AST) or alanine transaminase (ALT) =\< 2.5 x ULN 8. Alkaline phosphatase =\< 2.5 x UL 9. Negative serum or urine pregnancy test for women with reproductive potential. 10. A negative donor-specific antibody (DSA) assay (i.e., Micro-Flow Imaging (MFI) \<m3000) for recipients of any mismatched graft (including haploidentical) HCT. Exclusion Criteria: 1. Active disease (\>5% blasts or any evidence of extra-medullary disease) at the time of transplantation or at day +30 2. Active acute graft-versus-host disease (aGVHD) requiring systemic IST or history of aGVHD grade III or higher. 3. Active chronic GVHD requiring systemic immunosuppressive therapy (IST). 4. Active uncontrolled systemic fungal, bacterial, or viral infection 5. Known active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) 6. Significant active cardiac disease within the previous 6 months, including: New York Heart Association (NYHA) class III or IV congestive heart failure. Unstable angina, angina requiring surgical or medical intervention, and/or myocardial infarction. 7. History of any other malignancy within 2 years prior to study entry, except for: adequately treated in situ carcinoma of the cervix or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; myelodysplastic syndrome.
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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
-
University of Miami
Miami, Florida, 33136, United States
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Other studies related to the condition(s) this trial covers.
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