NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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

Outcome(s)

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 criteria1. first relapsed non-T-ALL and S2 according to ALL-REZ BFM S classification 2. Patients have not received any treatment after relapse. 3. Be<18 years-old at initial diagnosis and be <20 years-old at the enrollment 4. Have adequate hepatic, renal and cardiac function as indicated by laboratory values written in protocol. 5. Have a ECOG Performance Status Score of 0-2. 6. Parents(or leagal guardians) must provide signed, written informed consent.
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

Contact

public contact
Name Akiko Saito
Address National Nagoya Hospital, 4-1-1, Sannomaru, Naka-ku, Nagoya Japan
Telephone 052-951-1111
E-mail nsgdata@nnh.hosp.go.jp
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
E-mail chitoseo@qb3.so-net.ne.jp
Affiliation National Cancer Center Hospital Department of Pediatric Oncology