A Phase III Study on optimizing treatment for elderly patients with acute myeloid leukemia

Study on optimization and strategy for treatment of major hematologic diseases

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10001209

Enrollment

Unknown

Registered

2010-12-14

Start date

2010-09-03

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Elderly patients with acute myeloid leukemia

Interventions

C:consolidation therapy after complete response without autologous stem cell

A:HA±G-CSF for induction therapy

B:AA±G-CSF for induction therapy

D:consolidation therapy after complete response supported by autologous stem cell

Eligibility

Sex/Gender

All

Age

55 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. AML patients aged 55 to 69 years with newly diagnosed in the 31 study centers after August 1, 2010 as defined by the bone marrow cytomorphology, immunophenotyping, cytogenetics according to FAB classification and WHO classification (except APL); 2. Male or female, 70 > Age (years) >= 55; 3. ECOG 0, 1, or 2; 4. Patients must have the following laboratory values( within 7 days before treatment); 1) Total bilirubin 60 ml/min; 4) Myocardial enzymes <2 ULN (corrected for same ages); 5) Cardiac ejection fraction determined by echocardiography within normal range; 5. Able to swallow or per os; 6. Patients must complete the all listed screening assessment; 7. Patient must sign the informed consent prior to any study related screening procedures being performed.

Exclusion criteria

Exclusion criteria: 1. Patients previously receiving chemotherapy; 2. Patients receiving any other anticancer drugs outside this study; 3. Liver and kidney function was abnormal, beyond the inclusion criteria; 4. Other severe heart disease, including myocardial infarction, heart failure; 5. Patients with another primary malignancy (requiring active intervention at the same starting study time); 6. Patients with severe infections (including tuberculosis, pulmonary aspergillosis, etc); 7. Having history of drug dependence or mental illness; 8. The investigator believe that patient who are not suitable for this trial; 9. With other blood diseases at the same starting study time.

Design outcomes

Primary

Measure	Time frame
CR in different group;	—

Secondary

Measure	Time frame
Relapse in different group;DFS in different group;Death in different group;OS in different group;	—

Countries

China

Contacts

Public Contactjianxiang Wang

wangjx@medmail.com+86 22 23909120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026