JPRN-UMIN000023815
Completed
Phase 2
A Phase II study of combination chemotherapy including Bortezomib in pediatric patients with relapsed acute lymphoblastic leukemia (Investigator-initiated clinical trial) - Bortezomib for relapsed ALL (BZM-ALL-2)
Department of Pediatric Oncology, National Cancer Center Hospital0 sites22 target enrollmentSeptember 9, 2016
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- 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).
- Sponsor
- Department of Pediatric Oncology, National Cancer Center Hospital
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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