Clinical trial · Interventional
Study of the Beach Regimen on Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
An Exploratory Clinical Study of the Beach Regimen on Relapsed/Refractory Acute Myeloid Leukemia for Prospective, Single-arm, Phase II
NCT07651475CI-TRIAL-00114840active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the efficacy and safety of the Beach regimen on relapsed/refractory acute myeloid leukemia
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| R/R AML | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCL-2 inhibitor, Zemestosita, Azacitidine, Cytarabine, Chidamide, and G-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R/R AML
- description
- The experimental group: R/R AML The control group: N/A Drug: BCL-2 inhibitor, Zemestosita, Azacitidine, Cytarabine, chidamide, and G-CSF
- interventionNames
- Drug: BCL-2 inhibitor, Zemestosita, Azacitidine, Cytarabine, Chidamide, and G-CSF
Primary outcomes (1)
- measure
- Composite Complete Remission Rate (CRc)
- timeFrame
- one year after treatment
- description
- CRc = Complete Remission (CR) + Complete Remission with incomplete hematologic recovery (CRi)
Secondary outcomes (1)
- measure
- Overall Response Rate (ORR) - one year
- timeFrame
- one year after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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. -
References
Publications (0)
Data not yet available
No reference posted for this study.