Therapeutic role of homoharringtonine in acute promyelocytic leukemia, an open label randomised controlled trial

An open randomised trial of therapeutic role of homoharringtonine in acute promyelocytic leukemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000504

Enrollment

Unknown

Registered

2009-08-25

Start date

2009-08-25

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

acute promyelocytic leukemia

Interventions

high WBC group 1:Induction therapy with combination of arsenic trioxide and homoharringtonine. After achieved CR, patients receive consolidation treatment with combination of cytarabine and homoharrin

high WBC group 2:Induction therapy with combination of arsenic trioxide and daunorubicin. After achieved CR, patients receive consolidation treatment with combination of cytarabine and daunorubicin or

common group 1:Induction therapy with combination of all-trans retinoic acid and homoharringtonine. After achieved CR, patients receive consolidation treatment with combination of cytarabine and homoh

common group 2:Induction therapy with combination of all-trans retinoic acid and daunorubicin. After achieved CR, patients receive consolidation treatment with combination of cytarabine and daunorubic

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age: 15-60 years, male or female; 2. Acute Promyelocytic Leukaemia as defined by morphology and genetics (t(15;17) and/or PML-RARa positive); 3. General state of health: ECOG 0-2 grade; 4. Subjects meet the following criteria for the clinical laboratory: CR<=2.0*N, TB<=1.5*N, AST and ALT<=2.5*N, myocardial enzymes<=2.0*N; 5. HIV negative; 6. Signed informed consent if the patient older than 18 years. Signed informed consent by the patient's guardian if the patient younger than 18 years. Signed informed consent by the patient's guardian or linear relative if there are disadvantages about patient therapy signed by the patient.

Exclusion criteria

Exclusion criteria: 1. Psychotic states which are unfavorable to informed consent, participation and follow-up; 2. Serious complication or concomitant diseases; 3. Serious organ dysfunction or disease, such as dysfunction or disease of heart, liver, kidney, pancreas and so on; 4. The physician consider that the patient is not suitable for the trial.

Design outcomes

Primary

Measure	Time frame
disease free survival;complete remission;overall survival;molecular remission;	—

Secondary

Measure	Time frame
tolerability;	—

Countries

China

Contacts

Public ContactJianxiang Wang

wangjx@ihcams.ac.cn+86 022 23909120

Outcome results

None listed

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