WHO ICTRP trial

Study of the efficacy and safety of gemtuzumab ozogamicin treatment intervention…

JPRN-jRCTs041200063 · Japan Primary Registries Network (JPRN) · Recruiting

Key facts

Trial ID JPRN-jRCTs041200063
Public title 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)
Scientific title 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)
Primary sponsor Toshihiro Miyamoto
Registry Japan Primary Registries Network (JPRN)
Recruitment status Recruiting
Study type Interventional
Phase 2
Conditions AML with t(8;21)(q22;q22);RUNX1-RUNX1T1 or inv(16)(p13.1q22)/t(16;16)(p13.1;q22);CBFB-MYH11 AML, t(8;21)(q22;q22);RUNX1-RUNX1T1, inv(16)(p13.1q22)/t(16;16)(p13.1;q22);CBFB-MYH11
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 patients who have gained less than 3-log…
Registration date Nov 13, 2020
Target size 117
Registry page jrct.niph.go.jp

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