A phase I study (investigator-initiated) on the safety and pharmacokinetics of Bortezomib with combination chemotherapy in pediatric and young adult patients with refractory acute lymphocytic leukemia
- Conditions
- Refractory acute lymphocytic leukemia(ALL) in children and young adults
- Registration Number
- JPRN-UMIN000015980
- Lead Sponsor
- St.Luke's International Hospital Daisuke Hasegawa National Hospital Organization Nagoya Medical Center Naoko Maeda Fukushima Medical University Hospital Atsushi Kikuta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 3
Not provided
1) Mature B-cell ALL (L3) 2) Previous treatment with Bortezomib 3) The following complications/previous histories: 1. Concurrent infection requiring systemic treatment at enrollment. 2. Previous cardiac disease: previous myocardial infarction/angina pectoris within 12 months before enrollment. 3. Patients requiring oxygenation or showing respiratory insufficiency. 4. Previous interstitial pneumonia or pulmonary fibrosis. 5. Abnormal pulmonary function test, KL-6, SP-D, and SP-A as demonstrated by screening tests. 6. Abnormal beta-D glucan, Candida antigen, and Aspergillosis antigen as demonstrated by screening tests. 7. Previous deep fungus infection. 8. CNS or peripheral disorder. 9. Other complications determined to seriously compromise conducting of the study (for example, uncontrollable diabetes). 4) Down syndrome 5) Active double cancer (simultaneous double cancer, and metachronous double cancer with up to a 5-year disease-free period; carcinoma in situ determined as cured with local therapy or lesions consistent with intramucosal carcinoma are not included in double cancer.) 6) Determined as difficult to participate in the study because of complicated psychiatric disease or mental symptoms. 7) Participation in other clinical studies, excluding those of ALL, within 30 days after obtaining consent. 8) Pregnant or possibly pregnant women. Breastfeeding women. Men and women providing no consent to avoiding pregnancy during the study. 9) Previous hypersensitivity to mannitol, boron, or other components of Bortezomib. 10) Patients determined as ineligible for participation in the study by an investigator/sub-investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity (DLT) Pharmacokinetics of Bortezomib
- Secondary Outcome Measures
Name Time Method Complete remission(CR) after induction therapy Minimal residual disease after induction therapy