Randomized, phase III, non-inferiority trial of low- versus standard-dose chemotherapy for induction remission of children and adolescents with acute myeloid leukemia (CALS III-AML18)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800015883

Enrollment

Unknown

Registered

2018-04-26

Start date

2018-06-01

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

children and adolescents with acute myeloid leukemia

Interventions

Low dose chemotherapy group:Mitoxantrone + cytarabine + granulocyte colony-stimulating factor

Standard dose chemotherapy group:Daunorubicin + cytarabine + etoposide

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed AML patients, including granulocytic sarcoma and MDS-RAEBT; 2. Patients younger than 18 years old; 3. Newly diagnosed patients without treatment, excluding single dose of intrathecal injection and use of hydroxyurine or cytarabine (cytarabine was used no more than 5 days, with a total dose less than 1g)for hyperleukin (WBC > 50 * 109/L at diagnosis); anticancer therapy for this malignancy within 2 weeks before study entry with the exception of IT therapy, hydroxyurea, or low-dose cytarabine as stated above 4. Patients or / and guardians who have signed the Informed Consent Form; 5. Patients predicted life would be more than 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed of acute promyelocytic leukemia (APL); 2. Patients diagnosed of juvenile myelomonocytic leukemia (JMML); 3. Fanconi anemia (FA) developed AML; 4. Down syndrome developed AML; 5. AML secondary to any other congenital disease; 6. Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol; 7. Use of anticancer therapy for this malignancy within 2 weeks before study entry with the exception of IT therapy, hydroxyurea, or low-dose cytarabine as stated above; 8. Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.Under such circumstances, all the research institutes are required to report directly to the person in charge of the project and decide whether to the exclude the case; 9.ECOG score 4.

Design outcomes

Primary

Measure	Time frame
remission state of bone marrow;remission state of hematology;disappear of extramedullary invasion;Event-free survival;Overall survival;early mortality rate;cumulative disease rate of relapse;	—

Countries

China

Contacts

Public ContactHu Shaoyan

Children's Hospital of Soochow University

hushaoyan@suda.edu.cn+86 0512-80692929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 13, 2026