NIPH Clinical Trials Search

UMIN ID: UMIN000002025

Registered date:01/06/2009

Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-II: Multicenter phase II clinical trial for children with non-T-ALL in intermediate risk group stratified by the minimal residual disease (MRD).

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedfirst relapsed acute lymphoblastic leukemia in children
Date of first enrollment2009/06/01
Target sample size69
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Patients with negative MRD at BMA3, treatment with arm A: chemotherapy Patients with positive MRD at BMA3, treatment with arm B: allogeneic stem cell transplantation


Primary Outcome3 year-event free survival rate (3y-EFS)
Secondary Outcome3 year-overall survival rate(3y-OS) Remission induction rate 3y-EFS and 3y-OS in MRD positive and negative groups Second progression free survival Incidence rates of adverse effects

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximum20years-old
GenderMale and Female
Include criteria
Exclude criteria1. Patients with mature B-ALL, Ph positive ALL or MLL rearrangement positive ALL. 2. Down syndrome 3. Have any severe bleeding in CNS system. 4. Have an uncontrolled systemic infection. 5. Are pregnant or lactating. 6. Have received a HSCT or organ transplantation. 7. Have a congenital or aquired immunodifficiency syndrome. 8. Patients can not be treated with one or more drugs in the protocol.

Related Information


public contact
Name Akiko Saito
Address National Nagoya Hospital, 4-1-1, Sannomaru, Naka-ku, Nagoya Japan
Telephone 052-951-1111
Affiliation Japanese Pediatric Leukemia/Lymphoma study Group Data Center
scientific contact
Name Chitose Ogawa
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo Japan
Telephone 03-3542-2511
Affiliation National Cancer Center Hospital Department of Pediatric Oncology