New cocktail aims to tame dangerous leukemia in High-Risk patients
NCT ID NCT07187505
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether adding venetoclax to the standard two-drug regimen (ATRA and arsenic trioxide) can help patients with a rare blood cancer called acute promyelocytic leukemia (APL) who have very high white blood cell counts. These patients often face serious complications and higher early death rates. The trial will enroll 28 newly diagnosed adults and teens to see if the combination is safe and reduces early deaths.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Venetoclax (a drug that helps leukemia cells die), all-trans retinoic acid (ATRA), and arsenic trioxide (ATO)
- What this could lead to
- If successful, this combination could improve survival and reduce early complications for APL patients with very high white blood cell counts, a group that currently has poor outcomes.
- What could go wrong
- This is a small, early-phase study with only 28 participants and no control group, so results may not apply broadly. Adding venetoclax could also increase side effects like low blood counts or infections.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2027
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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14 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: 1. Patients diagnosed with acute promyelocytic leukemia (APL) according to bone marrow morphology and immunophenotyping, consistent with the WHO 2016 diagnostic criteria. 2. Age ≥14 years, both male and female patients are eligible. 3. Adequate organ function, defined as: 3.1 Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3 × upper limit of normal (ULN); 3.2 Total serum bilirubin ≤1.5 × ULN; 3.3 Creatinine clearance ≥30 mL/min; 3.4 Serum cardiac enzymes \<2.0 × ULN. 4. Signed informed consent obtained from the patient or a legally authorized representative. 5. White blood cell (WBC) count \>10 × 10⁹/L at initial diagnosis, or WBC \>10 × 10⁹/L during treatment. Exclusion Criteria: 1. Diagnosis of acute non-promyelocytic leukemia, myeloid sarcoma, or chronic myeloid leukemia in accelerated or blast phase. 2. Known hypersensitivity to any drug included in the study regimen. 3. Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use effective contraception during the study treatment period. 4. Presence of organic heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months prior to screening that resulted in clinical symptoms or impaired cardiac function (NYHA class ≥III). 5. Concurrent malignancies, except for: 5.1 Malignancies treated with curative intent (e.g., hematopoietic stem cell transplantation) and with no known active disease for ≥5 years before enrollment; 5.2 Adequately treated non-melanoma skin cancer or malignant lentigo without evidence of disease, even if diagnosed \<3 years before enrollment; 5.3 Adequately treated carcinoma in situ without evidence of disease, even if diagnosed \<3 years before enrollment. 6. Patients with acquired immunodeficiency syndrome (AIDS) or syphilis, or those with active hepatitis B (detectable HBV DNA) or active hepatitis C infection. 7. Any concurrent medical condition or disease that may interfere with study procedures or outcomes, or that may pose an unacceptable risk to the participant as determined by the investigator (e.g., active systemic infection). 8. Inability to understand or comply with the study protocol. 9. Participation in another clinical study within 1 month prior to enrollment.
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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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Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road
Hefei, Anhui, 230022, China
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