JRCT ID: jRCTs041180144
Registered date:29/03/2019
JPLSG-ALL-Ph13
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
Date of first enrollment | 31/10/2013 |
Target sample size | 44 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Chemotherapy combined with imatinib or dasatinib. |
Outcome(s)
Primary Outcome | Three years event free survival |
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Secondary Outcome | 1. 3 year overall survival (OS) 2. Three-year OS of imatinib group, no dasatinib transplant group, dasatinib transplant group 3. 3-year EFS of imatinib group, no dasatinib transplant group, dasatinib transplant group 4. Introduction rate of remission after completion of remission induction therapy (IA) combined with imatinib 5. Remission induction rate after completion of imatinib combination early strengthening therapy (IB), dasatinib combination early strengthening therapy (IB) and total early strengthening therapy (IB) 6. Temporal change of minute residual lesions (Ig / TCR PCR MRD, FCM MRD, chimeric gene MRD) of TKI combined chemotherapy 7. Relationship between long-term prognosis and MRD before transplant 8. Relation between BCR-ABL chimeric gene mutation and MRD disappearance rate / MRD recurrence rate 9. Relation between IKZF1 gene deletion and MRD disappearance rate, MRD recurrence rate 10. Search for prognostic factors by genome analysis, epigenome analysis, transcriptome analysis of Ph + ALL cells 11. Relationship between imatinib blood concentration and dasatinib blood concentration and MRD elimination rate , MRD recurrence rate 12. Relationship between Imatinib blood concentration and Dasatinib blood concentration and adverse events 13. Evaluation of patient QOL obtained by questionnaire survey by himself and family (surrogate evaluation) 14. Adverse Event Incidence 15. Implementation rate of transplant in the first remission phase |
Key inclusion & exclusion criteria
Age minimum | >= 1age old |
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Age maximum | <= 19age old |
Gender | Both |
Include criteria | 1) diagnosis of Ph+ALL 2) age between 1 and 19 years old 3) ECOG performance status (PS) score of 0-3 4) no history of previous chemotherapy or radiation therapy 5) written informed consent obtained from patient or guardians. |
Exclude criteria | 1) uncontrolled infection, including active tuberculosis and positive of HIV antibody. 2) pregnancy or high possibility of pregnancy and giving suck wiman. 3) history of congenital or acquired immunodeficiency. 4) any inappropriate status judged by physician. |
Related Information
Primary Sponsor | Sato Atsushi |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Agency for Medical Research and Development,National Center for Child Health and Development |
Secondary ID(s) | UMIN000011946 |
Contact
Public contact | |
Name | Atsushi Sato |
Address | 4-3-17 Ochiai, Aoba-ku, Sendai, Miyagi Miyagi Japan 989-3126 |
Telephone | +81-22-391-5111 |
asatoh@miyagi-children.or.jp | |
Affiliation | Miyagi Children's Hospital |
Scientific contact | |
Name | Atsushi Sato |
Address | 4-3-17 Ochiai, Aoba-ku, Sendai, Miyagi Miyagi Japan 989-3126 |
Telephone | +81-22-391-5111 |
asatoh@miyagi-children.or.jp | |
Affiliation | Miyagi Children's Hospital |