RecruitingPhase 1NCT03571321

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

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

Enrollment

15 participants

Start Date

May 28, 2019

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called ruxolitinib to standard chemotherapy improves outcomes for teenagers and young adults with a specific, high-risk type of acute lymphoblastic leukemia (ALL) called "Ph-like ALL," which has certain genetic features that make it harder to treat. **You may be eligible if...** - You have been newly diagnosed with Ph-like B-cell ALL (a specific type of blood cancer with particular genetic markers) - Your cancer has a JAK-pathway-targetable genetic signature (such as CRLF2 rearrangement, JAK2 or EPOR fusion, or related mutations) - You are an adolescent or young adult meeting the age requirements of the study **You may NOT be eligible if...** - Your ALL does not have the Ph-like genetic signature - Your cancer does not carry the specific genetic changes that ruxolitinib targets - You have already been treated for this diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRuxolitinib

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

DRUGCyclophosphamide

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

DRUGCytarabine

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

DRUGMercaptopurine

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

DRUGVincristine

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

DRUGPegaspargase

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.

DRUGRituximab

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

DRUGMethotrexate (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)

DRUGMethotrexate (Intravenous Administration)

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

DRUGDexamethasone

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

DRUGDoxorubicin

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

DRUGThioguanine

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

DRUGMethotrexate 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\]


Locations(1)

University of Chicago Medical Center

Chicago, Illinois, United States

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NCT03571321


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