At a glance
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Phase II Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide (CTX), Vincristine, and 6 other interventions for Acute Lymphoblastic Leukemia. Completed, enrolled 90 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if a special combination of chemotherapy drugs called "augmented hyper-CVAD chemotherapy" given over 6 to 8 months followed by monthly maintenance chemotherapy for one year can help to control acute lymphoblastic leukemia or lymphoblastic lymphoma. The safety of this therapy will also be studied.
Study Details
Timeline
Interventions
300 mg/m\^2 by vein (IV) over 3 hours every 12 hours for 6 doses days 1, 2, 3 of
2 mg by vein (IV) weekly for 3: Days 1, 8, 15
50 mg/m\^2 by vein (IV) over 24 hours
80 mg by vein (IV) or by mouth (P.O.) daily days 1-4 and 15-18
10 mcg/kg/day (rounded) by vein (IV) or under the skin (subcutaneously) within 72 ± 48 hours
200 mg/m2 by vein (IV) over 2 hours followed by 800 mg/m2 over 22 hours on day 1
3 gm/m\^2 by vein (IV) over 2 hours every 12 hours for 4 doses on days 2 and 3.
2,500 units/m2 by vein (IV) on day 1 of odd courses and day 5 of even courses