A Multi-Center Phase II Study in Children and Adolescence with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia - ALL-T11

Watanebe Arata0 sites364 target enrollmentMarch 29, 2019

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Watanebe Arata
Enrollment: 364
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The clinical trial for newly diagnosed T-ALL patients aged less than 25 years old cooperatively conducted by Japan Children's Cancer Study Group and Japan Adult Leukemia Study Group has been implemented. This trial was a BFM-based treatment with the intensification of nelarabine and L-asparaginase. It showed encouraging and comparable outcomes to other clinical trials with acceptable toxicities.

Registry

who.int

Start Date

March 29, 2019

End Date

November 30, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Watanebe Arata

Eligibility Criteria

Inclusion Criteria

•1\) diagnosis of T\-ALL (CD3\+ or cyCD3\+ and more than one is positive among CD2, CD5, CD7, CD8\)
•2\) age less than 25 years old
•3\) ECOG performance status (PS) acore of 0\-2\.However, PS scores up to 3 are permitted when the deterioration of PS is thought to be due to leukemia.
•4\) no history of previous chemotherapy or radiation therapy
•5\) sufficient hepatic and renal function satisfying the laboratory data listed below ;
•(1\)T\-Bili: within 3x of age adjusted upper\-limit of normal range.
•(2\)Creatinine: within 3x of age adjusted upper\-limit of normal range.
•6\) written informed consent obtained from patient or guardians.

Exclusion Criteria

•1\) Intracranial hemorrhage more than grade 3 of CTCAE v4\.0
•2\) uncontrolled infection, including active tuberculosis and positive of HIV antibody.
•3\) pregnancy or high possibility of pregnancy and giving suck woman.
•4\) history of congenital or acquired immunodeficiency.
•5\) Down syndrome.
•6\) QTfc, corrected by Fridericia formula as QTfc \= QT/RR cube root, is more than 0\.45 seconds.
•7\) any inappropriate status judged by physician.