15
Participants
Start Date
May 28, 2019
Primary Completion Date
September 1, 2026
Study Completion Date
September 5, 2027
Ruxolitinib
"Participants will receive one of 3 doses \[taken by mouth\] (30 mg, 40 mg, or 50 mg) depending on when they are enrolled to the study.~Remission consolidation regimen:~* Days 1-14 and 29-43~Interim maintenance regimen:~* Days 1-14 and 29-43~Delayed Intensification regimen:~* Days 1-14 and 29-43"
Cyclophosphamide
"Remission consolidation regimen:~* 1000 mg/m2 by intravenous infusion (IV) on Day 1 and Day 29~Delayed Intensification regimen:~* 1000 mg/m2 IV on Day 29"
Cytarabine
"Remission consolidation regimen:~* 75 mg/m2/day IV or subcutaneously (SC) on Days 1-4 (i.e., 4 doses), 8-11, 29-32, and 36-39~Delayed Intensification regimen:~* 75 mg/m2/day IV or SC on Days 29-32 and 36-39"
Mercaptopurine
"Taken by mouth.~Remission consolidation regimen:~* 60 mg/m2 on Days 1-14 and 29-42~Maintenance Therapy:~* 75 mg/m2 on Days 1-84"
Vincristine
"Remission consolidation regimen:~* 1.5 mg/m2 (maximum 2 mg) IV once per week on Days 15, 22, 43, and 50~Interim maintenance regimen:~* 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 11, 21, 31, and 41~Delayed Intensification regimen:~* 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 8, 15, 43, and 50~Maintenance Therapy:~* 1.5 mg/m2 (maximum 2 mg) IV on Days 1, 29, and 57"
Pegaspargase
"Remission consolidation regimen:~* 2500 IU/m2 given by intramuscular (IM) injection or IV on Days 15 and 43~Interim maintenance regimen:~* 2500 IU/m2 IM or IV on Days 2 and 22~Delayed Intensification regimen:~* 2500 IU/m2 IM or IV on Day 4 (OR Day 5 OR Day 6) AND Day 43."
Rituximab
"For patients that have cluster of differentiation antigen 20 positive (CD20+) disease only.~Remission consolidation regimen:~* 375 mg/m2 IV on Days 1, 8, 29 and 36~Interim maintenance regimen:~* 375 mg/m2 IV on Days 1 and 11~Delayed Intensification regimen:~* 375 mg/m2 IV on Days 1 and 8"
Methotrexate (Intrathecal Administration)
"Drug is given through a needle which is inserted in one of the spaces between the bones in the lower back (intrathecal \[IT\] administration).~Remission consolidation regimen:~* 15 mg on Days 1, 8, 15, and 22~Interim maintenance regimen:~* 15 mg on Days 1 and 31~Delayed Intensification regimen:~* 15 mg on Days 1, 29, and 36~Maintenance Therapy:~* 15 mg on Day 1~* 15 mg on Day 29 (First 4 courses only)"
Methotrexate (Intravenous Administration)
"Interim maintenance regimen:~* 100 mg/m2 IV on Days 1, 11, 21, 31, and 41"
Dexamethasone
"Taken by mouth or given by IV infusion.~Delayed Intensification regimen:~* 10 mg/m2 per day (divided into 2 doses) on Days 1-7 and 15-21~Maintenance Therapy:~* 6 mg/m2 per day (divided into 2 doses) on Days 1-5, 29-33, and 57-61"
Doxorubicin
"Delayed Intensification regimen:~* 25 mg/m2 IV on Days 1, 8, 15"
Thioguanine
"Taken by mouth at least 1 hour after evening meal.~Delayed Intensification regimen:~* 60 mg/m2 on Days 29-42"
Methotrexate Oral Product
"Taken by mouth.~Maintenance Therapy:~* 20 mg/m2 weekly (on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78)~* Not given on Day 29 of first 4 courses (on days when IT Methotrexate is given\]"
RECRUITING
University of Chicago Medical Center, Chicago
Collaborators (1)
Incyte Corporation
INDUSTRY
University of Chicago
OTHER