AML(acute myeloid leukemia and related neoplasms),MDS(myelodysplastic syndromes),CMML(chronic myelomonocytic leukemia)
Conditions
Interventions
None listed
Sponsors
Japan Adult Leukemia Study Group (JALSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Aged 16 or older with all newly diagnosed untreated AML, MDS, CMML at participating institutions. (2)Diseases are defined in accordance with WHO classification, 2016 edition. (3)Acute leukemias of ambiguous lineage (acute undifferentiated leukemia, mixed phenotype acute leukemia (MPAL)) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) are also included, except MDS/MPN other than CMML. In order to strictly apply the WHO classification 2016 edition, following examinations are required in addition to the commonly performed chromosome examination: SF3B1 mutation in MDS, NPM1 mutation in AML, double CEBPA mutation, and RUNX1 mutation. Confirming that the presence or absence of history of these genetic examinations, classification is made on the assumption that there is no mutation for the case of absence. In the case of diagnosing AML with myelodysplasia-related changes (AML-MRC) based on the preceding hematopoietic abnormality, it is assumed that a hematopoietic abnormality period of 3 months or more has been confirmed.
Exclusion criteria
Exclusion criteria: (1)With a history of chemotherapy or hematopoietic stem cell transplantation in AML, MDS or CMML; however, treatment-related AML, MDS and CMML which developed after the following therapies are included: therapy for preceding blood abnormalities (such as immunosuppressive therapy for aplastic anemia), chemotherapy for malignancy of other tissues, radiation therapy (such as radiation therapy for preceding breast cancer, chemotherapy for preceding malignant lymphoma). (2)In case of progress from MDS or CMML to AML, re-registration is not required if it is registered with preceding MDS or CMML. MDS and CMML which had already been diagnosed outside the JALSG participating institutions are excluded. The case which developed to AML after having been diagnosed as MDS by other than those institutions and transferred to the own institution is registered as AML (with preceding blood disease). (Even if the history of abnormality of blood count is long, newly diagnosed MDS and CMML in the own institution are not excluded.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival rate for AML 5-year overall survival rate for MDS 5-year overall survival rate for CMML | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Remission rate and survival rate in each therapy of initial induction therapy and re-induction therapy for AML. (2)Influence of use/non-use of azacitidine and gemutuzumab ozogamicin on survival rate in AML. (3)Remission rate and survival rate in each initial therapy using azacitidine in MDS. (4)Use/Non-use of lenalidomide, deferasirox and erythropoietin, and survival rate in MDS. (5)Remission rate and survival rate in each initial therapy using azacitidine in CMML. (6)Influence of situation at the time of allogeneic hematopoietic stem cell transplantation, and of presence/absence of donor source and family donor on survival rate. (7)Influence of comorbidity (by Charlson comorbidity index) on treatment outcome. | — |
Countries
Japan
Contacts
Public ContactHisayuki Yokoyama
Tohoku University Graduate School of Medicine Department of Hematology
Outcome results
None listed