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Efficacy and safety of BHA regimen for FLT3-mutated relapsed/refractory acute myeloid leukemia: a prospective, multi-center, single-arm clinical study

Efficacy and safety of BHA regimen for FLT3-mutated relapsed/refractory acute myeloid leukemia: a prospective, multi-center, single-arm clinical study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074321
Enrollment
Unknown
Registered
2023-08-03
Start date
2023-12-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FLT3 mutation acute myeloid leukemia

Interventions

experimental group:Bortezomib, homoharringtonine and Cytarabine combined chemotherapy (BHA) was used to induce remission chemotherapy, specifically Bortezomib 1.3mg/m2 d1,3,5 injection
Homoharringtonine 4mg/m2, d 1-5, intravenous drip once a day
Cytarabine 0.5g/m2, d 1-5, intravenous drip once a day.

Sponsors

The Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.AML (non-APL) was clearly diagnosed according to WHO criteria; 2.The disease state is relapsed or refractory; 3.FLT3 mutations were found, including FLT3-ITD and FLT3-TKD mutations; 4.Aged 18 to 65 years; 5.ECOG physical condition score was <= 3; 6.No serious complications, such as liver failure, renal failure, heart failure; 7.Must be able to understand the protocol, follow medical instructions and sign informed consent.

Exclusion criteria

Exclusion criteria: Patients with any of the following criteria were not eligible for this study: 1.Who is receiving either a chemotherapy regimen or a targeted drug; 2.Major surgery (excluding diagnostic surgery) performed within the past 4 weeks; 3.Evidence of central nervous system disease; 4.Active infectious diseases, such as HBV, HCV, tuberculosis; 5.Serious diseases that may limit patients' participation in the trial (such as progressive infection, uncontrolled diabetes, severe cardiac insufficiency or myocardial infarction, liver and kidney dysfunction, etc); 6.Participating in other clinical trials or participating in clinical trials of other drugs within 3 months; 7.Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during treatment and within a year thereafter; 8.There are allergies or contraindications to any of the drugs involved in the protocol; 9.Unable to understand the experimental protocol, follow the doctor's advice, or refuse to sign the informed consent; 10.The researchers say it is not appropriate for patients who are treated with this regimen.

Design outcomes

Primary

MeasureTime frame
Complete response rate ;

Secondary

MeasureTime frame
Drug safety;

Countries

China

Contacts

Public ContactJinsong Yan

Second Hospital of Dalian Medical University

yanjsdmu@126.com+86 177 0987 1028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 9, 2026