Implementation of targeted therapy during remission induction chemotherapy of de novo pediatric acute myeloid leukemia to improve rates of complete remission

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004398

Enrollment

170

Registered

2019-10-29

Start date

2021-07-13

Completion date

Unknown

Last updated

2021-08-30

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

Conditions

None listed

Interventions

Drug : *newly diagnosed de novo pediatric acute myeloid leukemia -Undertake studies to designate risk group and evaluate extent of disease: cytogenetic study, mutational analysis, whole body MRI -Ind

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 0-18 2) Newly diagnosed de novo AML (bone marrow (BM) blast = 20%), no previous therapy 3) Patients with recurrent genetic abnormalities found in AML, such as t(8;21), inv(16), t(16;16), even if the BM blast percentage is less than 20% 4) Patients who failed to achieve morphological and cytogenetic CR. Cytogenetic CR refers to any cytogenetic clone found at diagnosis (for example -7, 5q-) normalizing to 46, XX or 46, XY. If the patient had a normal karyotype at diagnosis, then only the morphology of the follow-up BM study will be used to determine CR.

Exclusion criteria

Exclusion criteria: 1) Acute promyelocytic leukemia (AML, M3) 2) Down syndrome AML 3) Therapy-related AML 4) AML that developed from myelodysplastic syndrome or other BM failure syndrome 5) Isolated myeloid sarcoma with normal BM 6) Serious complications (severe infection, intracranial bleeding) that prevent the start of normal chemotherapy 7) If the patient or legal guardian wishes to withdraw from the clinical trial 8) Presence of non-hematologic organ toxicity, as defined below - serum creatinine = 3 x upper normal limit - ejection fraction < 40%, or severe arrhythmia or conduction abnormality 9) Contraindications to targeted chemotherapy

Design outcomes

Primary

Measure	Time frame
rate of enet free survival	—

Secondary

Measure	Time frame
proportion of patients who achieved complete remission	—

Countries

Korea, Republic of

Contacts

Public ContactHyeonjeong Sa

The Catholic University of Korea, Seoul St. Mary's Hospital

likewandoi@naver.com+82-2-2258-2833

Outcome results