A phase III clinical trial evaluating efficacy and safety of minimal residual disease-based risk stratification for children with acute myeloid leukemia, incorporating a randomized study of gemtuzumab ozogamicin in combination with post-induction chemotherapy for non-low-risk patients - JPLSG-AML-20

Tomizawa Daisuke0 个研究点目标入组 500 人开始时间: 2021年5月10日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(1) Diagnosis of AML
•(2) Age 0 to <16 years at diagnosis
•(3) ECOG performance status (PS) score or JPLSG Infant Leukemia Committee PS score of 0 to 3; those with PS score 4 is also eligible if that is derived from AML
•(4) Newly diagnosed AML without prior therapy for AML; history of steroid, ATRA due to suspicion of APL, or single intrathecal methotrexate due to suspicion of ALL are permitted
•(5) Sufficient organ function meeting both laboratory data listed below (should be evaluated =<7 days of trial entry);
•Serum T-Bil: <3x of the age-dependent normal range
•Serum creatinine: <3x of the age-dependent normal range
•(6) Prior consent to participating the JPLSG-CHM-14 study is mandatory
•(7) Written informed consent from the legal guardian.

•(1) <36 week and 0 day gestational age, if age =<30 days at diagnosis
•(2) Patients with following diagnosis
•1) RARA-associated fusion gene positive acute promyelocytic leukemia (APL)
•2) AML associated with Down Syndrome (ML-DS)
•3) Secondary AML (history of congenital bone marrow failure syndrome, myelodysplastic syndrome, and/or prior chemotherapy)
•4) Ambiguous lineage acute leukemia (ALAL). ALAL with AML-specific genetic abnormalities are eligible
•5) Myeloid sarcoma
•(3) Uncontrollable infections (including active tuberclosis, HBV, and/or HCV)
•(4) Pregnant or lactating females
•(5) History of congenital or acquired immunodeficiencies
•(6) Presence of organ dysfunction interfering trial therapy
•a) Uncontrollable heart failure (presence of heart anomly itself is not a exclusion criteria)
•b) Uncontrollable renal failure
•c) Respiratory failure requiring mechanical ventilation
•d) >= grade 3 intracranial hemorrhage (CTCAE ver 5.0)
•(7) Presence of other malignant neoplasms
•(8) Other inappropriate status judged by physician
•(9) Patients considered as inappropriate to participate in the trial judged by the primary investigators and co-investigators

发起方

Tomizawa Daisuke