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).
Masanori YoshidaShin-Ichi TsujimotoShiro TanakaJun MatsubayashiTakahiro AokiShotaro IwamotoDaisuke HasegawaKozo NagaiKentaro NakashimaKoji KawaguchiTakao DeguchiNobutaka KiyokawaKentaro OhkiHidefumi HiramatsuNorio ShibaKiminori TeruiAkiko Moriya SaitoMotohiro KatoTakashi TagaTsugumichi KoshinagaSouichi AdachiPublished in: Japanese journal of clinical oncology (2022)
The purpose of this study is to establish a treatment with appropriate intensity for children (<16 years old at diagnosis) with de novo acute myeloid leukemia (excluding acute promyelocytic leukemia and myeloid leukemia associated with Down syndrome) according to a risk stratification based on recurrent leukemic cytogenetic abnormalities and flow-cytometric minimal residual disease at end of initial induction chemotherapy and to validate the safety and efficacy of gemtuzumab ozogamicin (GO)-combined post-induction chemotherapy for the non-low-risk (non-LR) patients. The primary endpoint of this phase III study is three-year disease-free survival rate, which will be compared between the GO and non-GO arms of the non-LR (intermediate-risk and high-risk [HR]) patients. All HR patients will be allocated to allogeneic hematopoietic stem cell transplantation in first remission. This trial has been registered at the Japan Registry of Clinical Trials (jRCTs041210015).
Keyphrases
- acute myeloid leukemia
- clinical trial
- phase iii
- end stage renal disease
- allogeneic hematopoietic stem cell transplantation
- newly diagnosed
- chronic kidney disease
- prognostic factors
- squamous cell carcinoma
- acute lymphoblastic leukemia
- phase ii
- randomized controlled trial
- young adults
- study protocol
- double blind
- rheumatoid arthritis
- patient reported
- acute respiratory distress syndrome
- placebo controlled
- intensive care unit
- mechanical ventilation