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Acute Lymphoblastic LeukemiaCancerDrugPhase 1

What this study is

This study will test if adding ruxolitinib to standard multi-drug chemotherapy regimen will be safe and tolerated in adolescents and young adults with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL).

What's being tested

  • Ruxolitinib

    Intervention · DRUG

    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

    Intervention · DRUG

    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

    Intervention · DRUG

    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

    Intervention · DRUG

    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

    Intervention · DRUG

    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

    Intervention · DRUG

    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

    Intervention · DRUG

    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)

    Intervention · DRUG

    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)

    Intervention · DRUG

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

  • Dexamethasone

    Intervention · DRUG

    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

    Intervention · DRUG

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

  • Thioguanine

    Intervention · DRUG

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

  • Methotrexate Oral Product

    Intervention · DRUG

    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]

Study details

Official title
Phase I Trial of Ruxolitinib in Combination With a Pediatric Based-regimen for Adolescents and Young Adults (AYAs) With Ph-like Acute Lymphoblastic Leukemia (ALL)
Sponsor
University of Chicago
Conditions
Acute Lymphoblastic Leukemia · ALL, Childhood · ALL
Enrolling
15 people
Starts
2019-05-28
Est. completion
2027-09-05
Design
Open-label, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗