Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-T11 and Japan Adult Leukemia Study Group (JALSG) T-ALL-211-U ALL-T11: A Multi-Center Phase II Study in Children and Adolescence with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-T11 and Japan Adult Leukemia Study Group (JALSG) T-ALL-211-U ALL-T11: A Multi-Center Phase II Study in Children and Adolescence with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia - A Multi-Center Phase II Study in Children and Adolescence with T-ALL: JPLSG/JALSG ALL-T11

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006851

Enrollment

147

Registered

2011-12-07

Start date

2011-12-01

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

T-cell Acute Lymphoblastic Leukemia

Interventions

Stratification(SR/HR/VHR) based on early prednisolone response, remission induction at time-point1(TP1) and MRD at time-point2(TP2). SR: Early prednisolone good responder (PGR), Time-point1(TP1):BM=

10*-3 . Clinical study question: safety and effectiveness of BFM-MR regimen with intensive L-asp and without Nelarabine. HR: Early prednisolone poor responder (PPR), TP1:BM=M1 and TP2:MRD&lt

10*-3 . Clinical study question: safety and effectiveness of BFM-HR regimen with intensive L-asp and Nelarabine. VHR: TP1:BM=M1 and TP2:MRD&gt

=10*-3 or TP1:BM=M2/M3 and TP2:BM=M1. Clinical study question: rondamization

BFM-HR block regimen vs high-dose dexamethazine containing regimen.

Eligibility

Sex/Gender

All

Inclusion 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 0-3 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

Exclusion criteria: 1) CNS hemorrage more than grade 3 of CACAE v3.0 2) uncontrolled infection, including active tuberculosis and positive of HIV antibody. 3) pregnancy or high possibility of pregnancy and giving suck wiman. 4) history of congenital or acquired immunodeficiency. 5) Down syndrome. 6) QTfc, corrected by Friderics formula as QTfc = QT/RR*1/3, is more than 0.45 seconds. 7) any inappropriate status judged by physician.

Design outcomes

Primary

Measure	Time frame
1) 3 years event free survival 2) MRD disappearance of VHR group in RCT	—

Secondary

Measure	Time frame
1) Overall survival (OS) 2) Remission induction rate 3) Adverse event (including acute and late effect of patients diagnosed at less than 18 years old)	—

Countries

Japan

Contacts

Public ContactAkiko Saito

Data center OSCR data center

oscrdata@nnh.hosp.go.jp052(951)1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026