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

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 - JPLSG-ThrombALL-B19&T19

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054674

Enrollment

350

Registered

2024-06-17

Start date

2022-01-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-precursor or T-cell acute lymphoblastic leukemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients enrolled at Japan Children's Cancer Group (JCCG) sites in the JPLSG-ALL-B19 or T19 Study conducted jointly by the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) and the Japan Adult Leukemia Study Group (JALSG). 2) Investigators 16 years of age or older who have obtained written consent to participate in the JPLSG-ThrombALL-B19&T19 study from the patient himself/herself (or from a legal guardian if the patient is a minority).

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. &ge;10 years vs. &ge;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.	—

Measure

Time frame

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. &ge;10 years vs. &ge;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.

—

Countries

Japan

Contacts

Public ContactTakashi Ishihara

Nara Medical University Department of Pediatrics

takakun@naramed-u.ac.jp0744-22-3051

Outcome results