Tokyo, April 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061136) titled 'An observational study to evaluate the impact of treatment strategies and patient-related factors on survival in patients with newly diagnosed Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), and Chronic Myelomonocytic Leukemia (CMML) at institutions participating in the Japan Adult Leukemia Study Group (JALSG)' on April 2.
Study Type:
Observational
Primary Sponsor:
Institute - JALSG
Condition:
Condition - Patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or chronic myelomonocytic leukemia (CMML) diagnosed at institutions participating in the Japan Adult Leukemia Study Group (JALSG).
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This is a multicenter prospective observational study based on a centralized registry that collects clinical and biomarker data from patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or chronic myelomonocytic leukemia (CMML) diagnosed at institutions participating in the Japan Adult Leukemia Study Group (JALSG). The study aims to determine the 3- and 5-year survival rates and to evaluate the associations between treatment outcomes, treatment strategies, and patient-related factors such as age and comorbidities.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 16
years-old
16 years at the time of informed consent.
Newly diagnosed and previously untreated AML (acute myeloid leukemia and related neoplasms), MDS (myelodysplastic syndromes), or CMML (chronic myelomonocytic leukemia) according to the Revised 4th Edition of the WHO Classification.
Patients with acute leukemias of ambiguous lineage (acute undifferentiated leukemia and mixed phenotype acute leukemia [MPAL]) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) are also eligible.
MDS/MPN (myelodysplastic/myeloproliferative neoplasms) other than CMML are excluded.
After receiving a full explanation regarding participation in this study, written informed consent was obtained from the patient (or, in the case of minors or adults with impaired capacity to consent due to cognitive decline, from a legal representative, or from both the patient and the legal representative) based on their full understanding and of their own free will.
Key exclusion criteria - If the principal investigator or a co-investigator determines that participation in this study is inappropriate.
Target Size - 2000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 09 Day
Date of IRB - 2026 Year 03 Month 05 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2032 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069656
Disclaimer: Curated by HT Syndication.
