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

Summary

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).

Conditions

• Acute Lymphoblastic Leukemia
• ALL, Childhood
• ALL

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\]

Sponsors & Collaborators

• Incyte Corporation

  collaborator INDUSTRY

• University of Chicago

  lead OTHER

Principal Investigators

• Wendy Stock, MD · University of Chicago

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-28

Primary Completion

2026-09-01

Completion

2027-09-05

FDA Drug

Yes

Countries

• United States

Study Locations