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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT03571321
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — 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 — 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 — 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 — 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 — 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 — 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 — 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) — 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) — DRUG
    Interim maintenance regimen: * 100 mg/m2 IV on Days 1, 11, 21, 31, and 41
  • Dexamethasone — 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 — DRUG
    Delayed Intensification regimen: * 25 mg/m2 IV on Days 1, 8, 15
  • Thioguanine — DRUG
    Taken by mouth at least 1 hour after evening meal. Delayed Intensification regimen: * 60 mg/m2 on Days 29-42
  • Methotrexate Oral Product — 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

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).

Key Dates

Start date
May 28, 2019
Status verified
Jan 2026
Primary completion
Sep 1, 2026
Completion
Sep 5, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib
    Participants will receive ruxolitinib in addition to standard chemotherapy. Standard Chemotherapy Consists of: * Remission consolidation therapy (lasting 8 weeks) * Interim Maintenance (lasting 8 weeks) * Delayed Intensification (lasting 8 weeks * Maintenance Therapy (12 week courses/84 day cycles lasting 2-3 years) Prior to study entry, patients must have completed a 4-drug induction therapy regimen with intrathecal chemotherapy (modified Berlin-Frankfurt-Münster (aBFM) regimen or equivalent) as per the institution standard of care.

Primary Outcome Measure

Feasibility of adding ruxolitinib to a standard-of-care pediatric-based chemotherapy regimen in adolescents and young adult patients as determined by rate of side effects seen when combination is given [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
Howie Weiner
[email protected]
(773) 702-2084
Wendy Stock, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

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By specialty
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By research site
University of Chicago Medical Center· Chicago, IL

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