At a glance
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Phase I/II Study of Hyper-CVAD Plus RAD001 (Everolimus) for Patients With Relapsed or Refractory Acute Lymphocytic Leukemia (ALL)
In Brief
A Phase 2 clinical trial evaluating Everolimus (RAD001), Cyclophosphamide, and 8 other interventions for Leukemia and Acute Lymphocytic Leukemia. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The goal of Phase I of this clinical research study is to find the highest tolerable dose of RAD001 (everolimus) when given in combination with the standard chemotherapy regimens to patients with ALL. The goal of Phase II of this study is to learn if the drug combinations can help to control ALL. The safety of these drug combinations will be also studied in both phases.
Study Details
Timeline
Interventions
Beginning dose of 5 mg tablets every other day by mouth followed by a big glass of water. First dose will occur 1 day before receiving chemotherapy.
300 mg/m\^2 intravenous (IV) over 3 hours every 12 hours x 6 doses on Days 1, 2, 3 (total dose 1800 mg/m2).
2 mg IV on Day 4 and Day 11 ± 2 days.
50 mg/m\^2 IV over 24 hours via central venous catheter on day 4, after last dose of Cyclophosphamide given.
40 mg IV or orally daily days 1-4 ± 2 days and days 11-14 ± 2 days.
600 mg/m\^2 IV continuous infusion daily for 24 hours days 1-3.
200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 IV over 22 hours day 1.
3 gm/m\^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.
50 mg IV over 2 hours approximately every 12 hours for 6 doses days 1-3.
10 mcg/kg/day (rounded) within 72 ± 48 hours after completion of chemotherapy until neutrophil recovery 1 x 109/L or higher. Pegfilgrastim (given at 6 mg subcutaneous for one dose approximately 24 hours after completion of the chemotherapy) may be substituted for G-CSF.