At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Pilot Trial of Bortezomib (PS-341, Velcade) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
In Brief
A Phase 2 clinical trial evaluating L-asparaginase, doxorubicin hydrochloride, and 13 other interventions for B-cell Adult Acute Lymphoblastic Leukemia and 7 related conditions. Completed, enrolled 148 participants across 171 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Given IM 6000 IU/m2/dose Days 2 and 9
Given IV 60 mg/m2/dose on Day 1
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22
Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9
Given PO or IV 40 mg/m2/day on Days 1-28
Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8
Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22
Given IV 100 mg/m2/dose on Days 1-5
Given IV 440 mg/m2/dose on Days 1-5
Given IV or SC 5 micrograms/kg/dose Only on Day 6
Given PO or IV 15mg/m2/dose q6h x 3 doses
Correlative studies
IV 5000 mg/m2/dose Block 2: Day 22