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New cocktail therapy aims to beat back stubborn leukemia
NCT ID NCT07651475
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a combination of six drugs, called the Beach regimen, in 32 adults with relapsed or refractory acute myeloid leukemia (AML). The goal is to see if this mix can bring about remission and improve survival. Participants receive the drugs in a specific schedule, and researchers track how many achieve complete remission or other positive responses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- combination of BCL-2 inhibitor, Zemestosita, Azacitidine, Cytarabine, Chidamide, and G-CSF
- What this could lead to
- If successful, this could offer a new treatment option for patients with hard-to-treat acute myeloid leukemia, potentially leading to remission.
- What could go wrong
- This is a small, early-phase trial with only 32 participants, so results may not apply broadly. The drug combination may cause side effects or fail to improve 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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 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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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. Age 18-75 years 2. Confirmed diagnosis of R/R AML 3. Adequate organ function: TBIL ≤2×ULN; ALT/AST ≤2.5×ULN; Cr ≤ULN or Ccr ≥50 mL/min 4. ECOG performance status ≤2 5. Life expectancy ≥4 months 6. No severe allergic history 7. Not participating in other interventional trials during study 8. Signed informed consent - Exclusion Criteria: 1. Hypersensitivity to any study drug 2. Dysphagia or uncontrolled gastrointestinal disease impairing oral intake 3. Acute promyelocytic leukemia (APL) 4. Prior treatment with EZH1/2 inhibitors 5. Allogeneic hematopoietic stem cell transplantation within 6 months 6. Participation in another interventional trial within 4 weeks 7. Smoking and excessive drinking have affected the evaluation of the test results; 8. Undergone major organ surgery within the previous 6 weeks and whose recovery was not complete 9. Severe chronic respiratory disease requiring continuous oxygen 10. Clinically significant cardiac, renal, hepatic, neurologic, or endocrine disease; Child-Pugh B/C cirrhosis 11. Active uncontrolled infection including HBV, HCV, HIV, syphilis 12. Pregnant or breastfeeding women; women planning pregnancy during study 13. The patients deemed unsuitable by the researchers to participate in this study. -
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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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Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.