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Clinical study of induction remission therapy for relapsed / refractory acute myeloid leukemia with BHA combined chemotherapy regimen

Clinical study of induction remission therapy for relapsed / refractory acute myeloid leukemia with BHA combined chemotherapy regimen

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029841
Enrollment
Unknown
Registered
2020-02-15
Start date
2019-10-01
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

relapsed / refractory acute myeloid leukemia

Interventions

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. Meet the diagnostic criteria for recurrent/refractory AML:After complete remission (CR), peripheral blood reappears in leukemia cells or bone marrow primordial cells > 5% or extramedullary leukemia cell infiltration;2 courses of treatment after standard regimen were ineffective;after CR, after consolidation and intensive treatment, recurrence within 12 months;Patients who relapsed after 12 months but failed to respond to conventional chemotherapy;2 or more recurrences;Extramedullary leukemia persists. 2. Aged 18 to 65 years; 3. ECOG physical condition score was <= 3; 4. No serious complications, such as liver failure, renal failure, heart failure; 5. Must be able to understand the protocol, follow medical instructions and sign informed consent.

Exclusion criteria

Exclusion criteria: Patients who met any of the following criteria were excluded: 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. 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 ContactYan Jinsong

The Second Affiliated Hospital of Dalian Medical University

yanjsdmu@126.com+86 17709871028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026