Study of the Beach Regimen on Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

NCT07651475 | Active Not Recruiting Phase 2

• 1 other identifier: Not yet assigned
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety of the Beach regimen on relapsed/refractory acute myeloid leukemia

Conditions

R/R AML

Outcome Measures

Primary Outcomes (1)

• Composite Complete Remission Rate (CRc)

  CRc = Complete Remission (CR) + Complete Remission with incomplete hematologic recovery (CRi)

  one year after treatment

Secondary Outcomes (1)

• Overall Response Rate (ORR) - one year

  one year after treatment

Study Arms (1)

R/R AML

EXPERIMENTAL

The experimental group: R/R AML The control group: N/A Drug: BCL-2 inhibitor, Zemestosita, Azacitidine, Cytarabine, chidamide, and G-CSF

Drug: BCL-2 inhibitor, Zemestosita, Azacitidine, Cytarabine, Chidamide, and G-CSF

Interventions

BCL-2 inhibitor, Zemestosita, Azacitidine, Cytarabine, Chidamide, and G-CSF DRUG

BCL-2 inhibitor, Zemestosita, Azacitidine, Cytarabine, chidamide, and G-CSF

R/R AML

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Confirmed diagnosis of R/R AML
• Adequate organ function: TBIL ≤2×ULN; ALT/AST ≤2.5×ULN; Cr ≤ULN or Ccr ≥50 mL/min
• ECOG performance status ≤2
• Life expectancy ≥4 months
• No severe allergic history
• Not participating in other interventional trials during study
• Signed informed consent -

You may not qualify if:

• Hypersensitivity to any study drug
• Dysphagia or uncontrolled gastrointestinal disease impairing oral intake
• Acute promyelocytic leukemia (APL)
• Prior treatment with EZH1/2 inhibitors
• Allogeneic hematopoietic stem cell transplantation within 6 months
• Participation in another interventional trial within 4 weeks
• Smoking and excessive drinking have affected the evaluation of the test results;
• Undergone major organ surgery within the previous 6 weeks and whose recovery was not complete
• Severe chronic respiratory disease requiring continuous oxygen
• Clinically significant cardiac, renal, hepatic, neurologic, or endocrine disease; Child-Pugh B/C cirrhosis
• Active uncontrolled infection including HBV, HCV, HIV, syphilis
• Pregnant or breastfeeding women; women planning pregnancy during study
• The patients deemed unsuitable by the researchers to participate in this study. -

Sponsors & Collaborators

• Liping Dou: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Interventions

Azacitidine; Cytarabine; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Arabinonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: Prospective Assignment

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: March 31, 2026
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-02

Locations

CN (1)