A high-risk group of pediatric patients with first relapse of ALLor refractory ALL (patients who develop 2nd or subsequent relapse, relapse after hematopoietic cell transplantation or fail to achieve remission induction with one or more therapies).
Conditions
Interventions
In addition to the standardized induction therapy, intravenous administration of Bortezomib will be given at a dose of 1.3mg/m2 on Days 1, 4, 8, and 11.
Sponsors
Department of Pediatric Oncology, National Cancer Center Hospital
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Acute lymphoblastic leukemia (ALL), except mature B-cell ALL 2) First relapsed patients who are classified as high risk (S3 or S4) in the Risk Classification for First ALL Relapse In expansion cohort, patients who develop 2nd or subsequent relapse, relapse after hematopoietic cell transplantation or fail to achieve remission induction with one or more therapies. 3) Patients who were 17 years or younger at the first onset and 19 years or younger at relapse. In expansion cohort, patients who were 17 years or younger at the first onset and 19 years or younger at the time of informed consent. 4) ECOG Performance Status 0 to 2 5) The percentage of blast cells in the bone marrow is 5% or higher. 6) Patients who received the last chemotherapy for first-onset ALL 7 or more days before the day of enrollment, and who have not started treatment of relapsed ALL In expansion cohort, patients who received the last chemotherapy for ALL 7 or more days before the day of enrollment. 7) Without following previous histories/complications: Grade 2 or worse CNS or peripheral nerve disorder Deep mycosis, interstitial pneumonia, pulmonary fibrosis Hypersensitivity to mannitol, boron, or other components of the drugs in the trial regimen 8) Patients meeting the following requirements as indicated by laboratory tests within 14 days before enrollment: 1. SpO2 >=96% and chest CT indicating no abnormal finding in the lung fields 2. KL-6, SP-D, beta-D glucan, Candida antigen, and Aspergillosis antigen are within normal range 3. AST, ALT: <= 5x ULN 4. Serum bilirubin: <= 2.0mg/dL 5. Creatinine: <= 2x ULN 6. 12-lead ECG indicating no abnormality requiring treatment and/or no abnormal conducting system 9) Patients who can receive PSL monotherapy and combination therapy during hospitalization 10) Consent to participate in this study obtained from the subject's representative
Exclusion criteria
Exclusion criteria: 1) Patients who received hematopoietic cell transplantation(only in high risk group of first relapse) 2) Patients who received allograft transplantation within 4 months(120 days) (only in expansion cohort) 3) Patients who received immunosuppressant within 14 days 4) Double cancer 5) Concurrent infection requiring systemic treatment at enrollment 6) Fever over 38.5 degrees Celsius 7) Pregnant or possibly pregnant women. Breastfeeding women. Men and women providing no consent to avoiding pregnancy during the study. 8) Determined as difficult to participate in the study because of complicated psychiatric disease or mental symptoms 9) The following complications or previous histories: Previous cardiac disease Patients with a history of continuous oxygen therapy required for treatment or a history of respiratory function impairment Patients with complications determined to seriously compromise conducting of the study (for example, uncontrollable diabetes) 10) CNS disorder 11) Down syndrome 12) Patients determined as ineligible for participation in the study by an investigator or a sub-investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission induction rate at the end of remission induction therapy using B-PVLDC-TIT regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Minimal Residual Disease (MRD) at the end of remission induction therapy using B-PVLDC-TIT regimen 2) 4-month event-free survival, overall survival, MRD at 4-month , where events are defined as relapse and death. 3) Proportion of the patients in remission and MRD at the start of transplantation conditioning 4) Duration of remission 5) Profile of adverse events occurring up to Day 28 of combination chemotherapy period | — |
Countries
Japan
Contacts
Public ContactMiwa Izutsu
CTD Inc. -
Outcome results
None listed