Myelodysplastic syndrome/acute myeloid leukemia
Conditions
Interventions
Case series:NA
Sponsors
Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients = 18 years old 2.Patients who have been diagnosed with MDS per WHO 2016 criteria with 10-19% blasts or diagnosed MDS/AML per the ICC 2022 criteria who have received first-line treatment or BSC with a minimum follow-up of 6 months (unless due to death) and for whom details of response, regardless of outcomes, are available.
Exclusion criteria
Exclusion criteria: 1.Patients aged < 18 years at the age of diagnosis. 2.MDS evolving from a pre-existing myeloproliferative neoplasm (MPN); MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) unclassified MDS/MPN, and therapy related MDS (tMDS), MDS with acute myeloid leukemia defining mutations or cytogenetics. 3.Current or previous participation in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from when diagnostic MDS/AML criteria (per the ICC 2022) were met to initial treatment or BSC.;Initial treatment, daily dosing, duration of treatment, treatment modification (i.e.,dose treatment interruptions, dose reductions, dose continuations), timing of bone marrow biopsy for response assessment, and where available, the reason rationale for treatment discontinuation and modification change if available, including supportive care agents/no active treatment in patients diagnosed with the new MDS/AML criteria.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient demographics and disease characteristics.;Subsequent treatments, daily dosing, duration of treatments, dosage modification (i.e., duration of end-of-cycle dose holds, reduced duration at end of cycle, dose delays between cycles, dose reductions), and where available, the reason rationale for treatment discontinuation and modification change if available, including supportive care agents/no active treatments in patients diagnosed with the new MDS/AML criteria.;Clinical response as per 2006 and 2023 IWG MDS response criteria, AML clinical response as per ELN 2022 criteria. Clinical outcomes as per IWG 2006 and 2023 MDS and AML ELN 2022 response criteria . ;Time to AML transformation and rate of transformation to AML in patients diagnosed with MDS/AML.;Rate of early death at 1 and 2 months of treatment in frontline and subsequent lines of treatment.;Number of infections requiring intravenous antibiotics, antifungals, or antivirals.;Rate of grade 3 and 4 treatment-emergent cytopenia as per CTCAE v5, febrile neutropenia, and TLS (tumor lysis syndrome (clinical and laboratory) based on Howard criteria .;Percentage of patients achieving transfusion independence (TI) who weretransfusion dependent when MDS/AML diagnostic criteria were met.;HCRU in patients diagnosed with the new MDS/AML criteria, based on median number transfusion requirements, granulocyte stimulating factor, erythropoiesis stimulating agent, antibiotic, antiviral, or antifungal utilization, hospitalizations, number of outpatient and ER visits.; | — |
Countries
China
Contacts
Public ContactZhijian Xiao
Hematology and Blood Diseases Hospital,Chinese Academy of Medical Sciences
Outcome results
None listed