Exploratory study using comprehensive coagulation and fibrinolysis functional analysis for hemostatic disorders associated with initial induction therapy and early consolidation therapy in pediatric, AYA and adult-onset B-precursor or T-cell acute lymphoblastic leukemia - A multi-factor analysis study incorporating trends in L-asparaginase activity

UMIN ID: UMIN000054674

Registered date:17/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: B-precursor or T-cell acute lymphoblastic leukemia
• Date of first enrollment: 2022/01/21
• Target sample size: 350
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Alterations in the comprehensive coagulation/fibrinolysis balance from the L-Asp treatment phase of initial induction therapy to the end of early consolidation therapy: Trends in thrombin-plasmin generation assay parameters.
• Secondary Outcome: From the L-Asp treatment phase of initial induction therapy to the end of early consolidation therapy: 1) Changes in platelet counts and conventional coagulation fibrinolysis markers. 2) Frequency of anticoagulation and transfusion therapy. 3) Frequency of hemostatic disorders (bleeding symptoms, thrombosis). 4) Comparison of the frequency of coagulopathy (bleeding symptoms, thrombosis) by age group (<10 years vs. ≥10 years vs. ≥15 years). 5) Comparison of the frequency of hemostatic disorders (bleeding symptoms, thrombosis) in patients with and without thrombophilia. 6) Comparison of the frequency of hemostatic disorders by the presence or absence of infections affecting bleeding symptoms or thrombosis.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 40years-old
• Gender: Male and Female
• Exclude criteria: 1) Infant ALL cases treated with a protocol other than the BFM backbone. 2) Ineligible cases such as Philadelphia chromosome-positive cases among ALL patients aged 1 year or older. 3) Other cases that the investigator or physician in charge of the study determines are not appropriate for participation in the study.

Related Information

• Primary Sponsor: Nara Medical University
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Grants-in-Aid for Scientific Research