refractory childhood acute lymphoblastic leukemia
Conditions
Interventions
Bortezomib combined with chemotherapy (TACL regimen)
Bortezomib combined with chemotherapy (UK-R3 regimen)
Sponsors
Department of Pediatrics, Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.patients with first induction failure (receving different two or more treatments, or childhood ALL (B precursor and T cell type except for relapse of extramedullary alone beyond first relapse). 2. patients in acknowledgment of the leukaemic cells more than 25% in marrow. 3. The patients of 1 year old or older and under 18 years old at the time of the first diagnosis, and below 20 years old at the time of registration of this study 4.The patients that Eastern Cooperative Oncology Score (ECOG) performance status(PS) score of the United States is 0-2 at the time of registration. 5.The patients whom it passes more than two weeks at the time of registration after lasttreatment and the patienss who resolved treatment (except the steroid) related toxicities except for myelosuppression. 6. The patients after 6 months or more following stem cell transplantation and no active GVHD at registration. In addition, it is necessary for the immunosuppressive drugs to be decreasing in the patients who are using the drugs. 7.The patient who meets all the following standards having enough livers, kidneys, cardiac function. The inspection level assumes it a value within 14 days from registration day. 2.0 mg/dl of serum total bilirubin levels or less More than 70 creatinine clearance ml/min/1.73m2 no abnormality needing treatment with an electrocardiogram 8.the patients whose agreement is provided in a document about the participation in this clinical trial from person themselves or parents (when subject is 16 years or older person themselves and parents).
Exclusion criteria
Exclusion criteria: 1. patients of Ph1-positive ALL which never receives treatment with tyrosine kinase inhibitor(TKI). 2.patients with Down syndrome. 3.patients with central nerve bleeding and the leukoencephalopathy more than CTCAE ver3.0 Grade3 affecting treatment accomplishment. 4.patients who had the past histories such as epilepsy, Guillain-Barre syndrome, and encephalitis. patients who have intractable epilepsy. 5.patients with uncontrolable infectious disease (including active tuberculosis and HIV infection) 6.patients during the pregnancy or patients who may be pregnant. 7.patients who had the past histories such as congenital or acquired immune deficiency 8. patients whom higher than one of the drugs included in this treatment plan cannot use by past treatment at all. 9.patient who had the past history of more than grade 2 peripheral neuropathy according to CTCAE ver4.0. 10.patients with allergy to mannitol and boron. 11.patients who received anthracyclines more than 350 mg/m2 by doxorubicin conversion in the past. 12.patients who had the past history of treatment-related interstitial pneumonia. Or patients with the abnormal interstitial shadow at the time of start of this study in CT. 13. patients who complicated with a second cancer other than recurrence ALL. 14.In addition, when physicians judge that it is inappropriate that the medical attendant participates in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose limiting toxicity (DLT) according to CTCAE4 beyond grade 3 except for blood system disorder | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. toxicities except for DLT 2. treatment response rates 3. rate of complete remission 4. event free survival for 4 months | — |
Countries
Japan
Contacts
Public ContactAkihiro Iguchi
Hokkaido University Hospital Pediatrics
Outcome results
None listed