Childrens Cancer and Leukemia Study Group (CCLSG) ALL2004 : A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Lymphoblastic Leukemia

Childrens Cancer and Leukemia Study Group (CCLSG) ALL2004 : A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Lymphoblastic Leukemia - A Multi-Center Phase II Study in Children with ALL: CCLSG ALL2004

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010488

Enrollment

230

Registered

2013-05-01

Start date

2004-06-01

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

Childhood acute lymphoblastic leukemia

Interventions

SR: Age 1-9 and initial WBC&lt

50,000mm3 HR: Age 1-9 and initial WBC more than 50,000/mm3 and WBC&lt

100,000/mm3, or Age 10-19 and initial WBC&lt

100,000/mm3 HHR: Age 1-19 and initial WBC more than 100,000/mm3 When point2:MRD more than 0.1%, SR group risk-up to Salvage1, HR and HHR group risk-up to Salvage2. No optional arm of auto- or allo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) diagnosis of ALL 2) age more than 1 year old and less than 19 years old. 3) ECOG performance status (PS) acore of 0-3 or Lansky performance status >=30. 4) no history of previous chemotherapy or radiation therapy. 5) sufficient hepatic and renal function satisfying the laboratory data listed below ; (1) T-Bill <=2 mg/dl (2) Creatinine: within age adjusted upper-limit of normal range. (3) AST: within x4 of the upper-limit of the institute upper-limit of normal range. 6) ECG showed normal corrected QT interval. 7) written informed consent obtained from patient or guardians. 8) Leukemic chimera geen screening has been investigated. 9) Pregnancy or other inadequate condition for attending the clinical trial.

Exclusion criteria

Exclusion criteria: 1) mature B-ALL 2) Ph+ALL : After registration, stop the protocol study with information of Ph+. 3) organ dysfunction for attending protocol study. 4) pregnancy or high possibility of pregnancy and giving suck woman. 5) history of congenital or acquired immunodeficiency. 6) uncontrollable infection 7) any inappropriate status judged by physician.

Design outcomes

Primary

Measure	Time frame
Primary endpoint 1) 3 years event free survival(3y-EFS) 1.1.3y-EFS difference between Point1:MRD(-) with Point2:MRD(-) group and Point1:MRD(+) with Point2:MRD(-) group 1.2.3y- EFS improving by the salvage therapy for Point2:MRD(+) group	—

Secondary

Measure	Time frame
Secondary endpoint 1) Severe adverse event rate in each risk- classification group. 2) Relationship between early prednisolone response and Poin1- and Point2-MRD. 3) Relationship between day15 bone marrow blast and Poin1- and Point2-MRD. 4) Relationship among Point3-,4-, 5-, 6-, 7- (at the end of protocol) MRD and relapse	—

Countries

Japan

Contacts

Public ContactHisanari Hori M.D.

Aichi Medical University School of Medicine Department of Pediatrics

hori@aichi-med-u.ac.jp0561-62-3311

Outcome results

None listed

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