Actively Recruiting

Phase 1
Age: 18Years - 39Years
All Genders
NCT03571321

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

Led by University of Chicago · Updated on 2026-01-09

15

Participants Needed

1

Research Sites

431 weeks

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

I

Incyte Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 39Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed de novo B-precursor acute lymphoblastic leukemia (ALL) confirmed by WHO criteria
  • Presence of Ph-like signature determined by low density micro-array card
  • Jak-targetable genetic signature including CRLF2 rearranged, JAK2 or EPOR fusions, or other JAK pathway alterations
  • Completion of a 4-drug induction regimen with intrathecal chemotherapy before starting ruxolitinib
  • No prior therapy for acute leukemia except emergency treatments like corticosteroids or hydroxyurea
  • Age 18 years to less than 40 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (Karnofsky 60% or higher)
  • Platelet count greater than 25,000 per microliter
  • Normal organ function with total bilirubin 2 mg/dL or less, AST/ALT less than or equal to 2.5 times institutional upper limit, and creatinine within normal limits or creatinine clearance 60 mL/min/1.73 m2 or higher
  • Agreement to use effective contraception during and after the study for men and women of child-bearing potential
  • Ability to understand and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Receiving any other investigational agent
  • Active second malignancy except non-melanoma skin cancer unless disease-free for 3 years or more
  • History of allergic reactions to ruxolitinib or similar compounds
  • Use of potent CYP3A4 inhibitors or inducers within 5 half-lives before starting study drug (except fluconazole at 200 mg daily)
  • Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
  • Pregnant or breastfeeding women
  • Down Syndrome due to risk of excessive toxicity
  • Burkitt type leukemia
  • Philadelphia chromosome positive (Ph+) ALL at diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

C

Clinical Trials Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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