A Phase II study of combination chemotherapy including Bortezomib in pediatric patients with relapsed acute lymphoblastic leukemia (Investigator-initiated clinical trial)

Phase 2

• 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).

• Registration Number: JPRN-UMIN000023815
• Lead Sponsor: Department of Pediatric Oncology, National Cancer Center Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-09
• Study Completion: 2020-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission induction rate at the end of remission induction therapy using B-PVLDC-TIT regimen

Secondary Outcome Measures

Name	Time	Method
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