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)

JRCT ID: jRCTs041200063

Registered date:13/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: AML with t(8;21)(q22;q22);RUNX1-RUNX1T1 or inv(16)(p13.1q22)/t(16;16)(p13.1;q22);CBFB-MYH11
• Date of first enrollment: 01/12/2020
• Target sample size: 117
• Study type: Interventional
• Intervention(s): 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 patients who have gained less than 3-log MRD reduction will receive HiDAC plus gemtuzumab ozogamicin for 3 cycles.

Outcome(s)

• Primary Outcome: 2 year relapse-free survival (RFS) following consolidation chemotherapy

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: < 65age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Toshihiro Miyamoto
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development