drugset / Trial / NCT00873093
Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
Timeline
- Start
- 2009-03
- Primary completion
- 2014-09
- Completion
- 2014-09
Publications
- Horton TM, Whitlock JA, Lu X, O'Brien MM, Borowitz MJ, Devidas M, Raetz EA, Brown PA, Carroll WL, Hunger SP. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol. 2019 Jul;186(2):274-285. doi: 10.1111/bjh.15919. Epub 2019 Apr 7.
- Hanley MJ, Mould DR, Taylor TJ, Gupta N, Suryanarayan K, Neuwirth R, Esseltine DL, Horton TM, Aplenc R, Alonzo TA, Lu X, Milton A, Venkatakrishnan K. Population Pharmacokinetic Analysis of Bortezomib in Pediatric Leukemia Patients: Model-Based Support for Body Surface Area-Based Dosing Over the 2- to 16-Year Age Range. J Clin Pharmacol. 2017 Sep;57(9):1183-1193. doi: 10.1002/jcph.906. Epub 2017 Apr 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 440 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 3000 mg/m2 | Intrathecal |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Background | Hydrocortisone | Other / unclassified | 8 mg | Intrathecal |
| Background | Hydrocortisone | Other / unclassified | 15 mg | Intrathecal |
| Background | Leucovorin | Small molecule | 15 mg/m2 | Oral |
| Background | Methotrexate | Small molecule | 8 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 15 mg | Intrathecal |
| Background | Methotrexate | Small molecule | 5000 mg/m2 | Intrathecal |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 iu | Intramuscular |
| Background | Prednisone | Other / unclassified | 40 mg/m2 | Oral |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | Intravenous |
| Background | asparaginase | Protein / enzyme biologic | 6000 iu | Intramuscular |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Intravenous |