Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia

PHASE1RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

May 28, 2019

Primary Completion Date

September 1, 2026

Study Completion Date

September 5, 2027

Conditions
Acute Lymphoblastic LeukemiaALL, ChildhoodALL
Interventions
DRUG

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"

DRUG

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"

DRUG

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"

DRUG

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"

DRUG

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"

DRUG

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."

DRUG

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"

DRUG

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)"

DRUG

Methotrexate (Intravenous Administration)

"Interim maintenance regimen:~* 100 mg/m2 IV on Days 1, 11, 21, 31, and 41"

DRUG

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"

DRUG

Doxorubicin

"Delayed Intensification regimen:~* 25 mg/m2 IV on Days 1, 8, 15"

DRUG

Thioguanine

"Taken by mouth at least 1 hour after evening meal.~Delayed Intensification regimen:~* 60 mg/m2 on Days 29-42"

DRUG

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\]"

Trial Locations (1)

60637

RECRUITING

University of Chicago Medical Center, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Incyte Corporation

INDUSTRY

lead

University of Chicago

OTHER