At a glance
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A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia
In Brief
A Phase 2 clinical trial evaluating Bortezomib, Dexamethasone, and 6 other interventions for Acute Lymphoblastic Leukemia. Completed, enrolled 31 participants across 24 sites in 4 countries.
Detailed Summary
This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.
Study Details
Timeline
Interventions
Intravenous on days 1, 4, 8 and 11. Dose assigned at study entry.
10 mg/m2/day divided BID, oral administration for 14 days.
2500 IU/m2/day, intramuscular injection on Days 2, 8, 15 and 22
60 mg/m2/day IV over 15 minutes on Day 1
Given intrathecally on Day 1 of course 1 at the dose defined by age below. * 30 mg for patients age 1-1.99 * 50 mg for patients age 2-2.99 * 70 mg for patients \>3 years of age
Given intrathecally to all patients who are CNS 1 at study entry on Day 15 at the dose defined by age below. * 8 mg for patients age 1-1.99 * 10 mg for patients age 2-2.99 * 12 mg for patients 3-8.99 years of age * 15 mg for patients \>9 years of age
1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22.
Triple IT therapy will be given intrathecally on Day 8, 15, and 22 for patients who are CNS 2 and CNS 3 at study entry. Regimen/dosing as follows: Methotrexate- * \<2 years: 8 mg * 2 - \<3 y: 10 mg * 3 - \<9 y: 12 mg * \>=9 y: 15 mg Cytarabine: * \<2 years: 16 mg * 2 - \<3 y: 20 mg * 3 - \<9 y: 24 mg * \>=9 y: 30 mg Hydrocortisone: * \<2 years: 8 mg * 2 - \<3 y: 10 mg * 3 - \<9 y: 12 mg * \>=9 y: 15 mg