NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041180144

Registered date:29/03/2019

JPLSG-ALL-Ph13

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPhiladelphia Chromosome Positive Acute Lymphoblastic Leukemia
Date of first enrollment31/10/2013
Target sample size44
Countries of recruitment
Study typeInterventional
Intervention(s)Chemotherapy combined with imatinib or dasatinib.

Outcome(s)

Primary OutcomeThree years event free survival
Secondary Outcome1. 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
Age maximum<= 19age old
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Atsushi Sato
Address 4-3-17 Ochiai, Aoba-ku, Sendai, Miyagi Miyagi Japan 989-3126
Telephone +81-22-391-5111
E-mail asatoh@miyagi-children.or.jp
Affiliation Miyagi Children&#039;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
E-mail asatoh@miyagi-children.or.jp
Affiliation Miyagi Children&#039;s Hospital