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A multicenter clinical study on the efficacy of homoharringtonine combined with three drugs in FLT3 / ITD + acute myeloid leukemia

A multicenter clinical study on the efficacy of homoharringtonine combined with three drugs in FLT3 / ITD + acute myeloid leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034405
Enrollment
Unknown
Registered
2020-07-04
Start date
2020-07-23
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Acute myeloid leukemia

Interventions

Group A:HIA scheme
Group B:HAD scheme

Sponsors

Shanxi Bethune Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with aged 18 to 60 years old male and female; 2. Patients with FLT3 / ITD + acute myeloid leukemia diagnosed by morphology, immunology and genetics of bone marrow cells were diagnosed according to the World Health Organization (who) diagnostic criteria, including patients with newly diagnosed and relapsed FLT3 / ITD + acute myeloid leukemia; 3. Patients who meet the diagnostic criteria for refractory AML (2011 Chinese guidelines for diagnosis and treatment of relapsed and refractory acute myeloid leukemia) (1) The patients who did not get complete remission after 2 courses of standard induction chemotherapy; (2) Patients who relapsed within 6 months after the first complete remission; (3) The patients who relapsed 6 months after the first complete remission were failed in the induction chemotherapy; (4) Patients with two or more relapses; (5) Patients with persistent extramedullary leukemia; 4. Patients meeting the diagnostic criteria of recurrent AML (refer to NCCN guidelines in 2014): after complete remission, peripheral blood cells appeared; bone marrow immature cells > 5%; extramedullary recurrence; 5. Choose HIA or had regimen according to patient's condition, medication history and economic condition; 6. Patients with ECOG-ps score of 0-2 in Eastern oncology collaboration group.

Exclusion criteria

Exclusion criteria: 1. Patients with cerebral hemorrhage; 2. The object of pregnancy; 3. Patients with mental illness or other conditions that cannot be carried out according to the plan; 4. Patients with severe arrhythmia and abnormal ECG (QT > 500ms); 5. Patients who do not sign informed consent form; 6. Other situations that the researcher thinks are not suitable for the group.

Design outcomes

Primary

MeasureTime frame
Complete remission rate;Relapse Rate;Event free survival;Overall survival;Peripheral blood primitive cell count in agranulocytosis;

Countries

China

Contacts

Public ContactTao Wang

Shanxi Bethune Hospital Affiliated to Shanxi Medical University

wangtao99699@163.com+86 13835175119

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026