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) studied | first relapsed acute lymphoblastic leukemia in children |
| Date of first enrollment | 2009/06/01 |
| Target sample size | 69 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| 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 Outcome | 3 year-event free survival rate (3y-EFS) |
|---|---|
| Secondary Outcome | 3 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 minimum | Not applicable |
|---|---|
| Age maximum | 20years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. 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
| Primary Sponsor | Japanese Peditric Leukemia/Lymphoma Study Group(JPLSG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Akiko Saito |
| Address | National Nagoya Hospital, 4-1-1, Sannomaru, Naka-ku, Nagoya Japan |
| Telephone | 052-951-1111 |
| 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 |
| chitoseo@qb3.so-net.ne.jp | |
| Affiliation | National Cancer Center Hospital Department of Pediatric Oncology |