Study of the efficacy and safety of gemtuzumab ozogamicin treatment intervention with measurable residual disease as an index for AYA/adult acute myeloid leukemia with t(8;21) and inv(16)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041200063

Enrollment

117

Registered

2020-11-13

Start date

2020-12-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

AML with t(8

Interventions

After remission indcution treatment, CBF-AML patients reaching a complete remission (CR) who have obtained more than 3-log MRD reduction undergo high-dose of cytarabine (HiDAC) for 3 cycles, while pat

MRD, gemtuzumab ozogamicin, high-dose cytarabine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed as core-binding factor acute myelogenous leukemia (CBF-AML) 2.Quantitative detection of RUNX1-RUNX1T1 or CBFB-MYH11 mRNA at presentation 3.Patients who are planned to undergo or are ongoing the standard '7+3' AML indcution chemotherapy 4.Patients who have not received consolidation chemotherapy 5. AML bast cells express CD33 on cell surface 6.ECOG performance status score 0,1,2 7.Having sufficient function of liver, kidney, lung, and heart 8.Having ablitity to concent with chemotherapy for AML in written forms 9.For patients younger than 20 years, consent of the person in charge must be obtained along with individual

Exclusion criteria

Exclusion criteria: 1.Myelodysplastic syndrome-derived or atypical AML 2.Patients who have had Down syndrome or congenital disease 3.Patients with a history of hematological disorders prior to enrollment into this study 4.Patients in whom measurable residula disease (MRD) anayses have been done after induction therapy 5.Patients who have been treated with gemtuzumab ozogamicin (GO) during induction chemotherapy 6.Patinets who have other active cancer 7.Patients with a history of myocardial infarction within a year 8.Diabetic patients with poor control 9.Patients with infectious complications with poor control 10.Patients with liver cirrhosis 11.Patients with a history of renal insufficiency 12.Patients with deep venous thrombosis to be treated 13.Patients who have mental disorders 14.Pregnant women 15.HBs antigen positive, or HCV antibody positive

Design outcomes

Primary

Measure	Time frame
2 year relapse-free survival (RFS) following consolidation chemotherapy	—

Secondary

Measure	Time frame
1.2 year overall survival (OS) following consolidation chemotherapy 2.Relationship between MRD and survival rate 3.Relationship between genetic alterations and response rate 4.Relationship between genetic alterations and survival rate 5.Safety and incidence of adverse event	—

Contacts

Public ContactMiyamoto Toshihiro

KANAZAWA UNIVERSITY HOSPITAL

toshmiya@staff.kanazawa-u.ac.jp+81-76-265-2270

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026