Actively Recruiting
Phase I Trial of Ruxolitinib Combined With Pediatric-based Chemotherapy for 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
52 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
Researchers are evaluating whether adding the drug ruxolitinib to a standard multi-drug chemotherapy regimen is safe and manageable in adolescents and young adults newly diagnosed with Philadelphia chromosome-like (Ph-like) acute lymphoblastic leukemia (ALL). This phase 1 trial focuses on this specific subtype of ALL, aiming to determine the side effects when combining ruxolitinib with chemotherapy. The study is sponsored by the University of Chicago and targets patients aged 18 to 39 years. Participants will receive ruxolitinib by mouth in doses of 30 mg, 40 mg, or 50 mg depending on enrollment timing. This is combined with a pediatric-based chemotherapy regimen consisting of remission consolidation therapy (8 weeks), interim maintenance (8 weeks), delayed intensification (8 weeks), and maintenance therapy given in 12-week cycles lasting 2 to 3 years. Chemotherapy drugs include cyclophosphamide, cytarabine, mercaptopurine, vincristine, pegaspargase, rituximab (for certain patients), methotrexate (both intrathecal and intravenous), dexamethasone, doxorubicin, thioguanine, and oral methotrexate. Prior to study entry, patients must have completed a 4-drug induction therapy regimen with intrathecal chemotherapy. During the study, participants will be monitored for side effects to assess the feasibility of adding ruxolitinib to chemotherapy over 24 weeks. Researchers will also evaluate the rate of minimal residual disease negativity at the end of induction therapy, overall survival, and event-free survival over two years. Participants will undergo regular assessments to track treatment tolerance and disease response. The total study duration includes multiple treatment phases lasting several years with ongoing follow-up to understand long-term outcomes and safety.
CONDITIONS
Brief Title
Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed de novo B-precursor acute lymphoblastic leukemia (ALL) confirmed by WHO criteria
- Ph-like signature confirmed by low density micro-array (LDA) card
- Presence of Jak-targetable genetic signature such as CRLF2 rearrangement, JAK2 or EPOR fusions, or other JAK pathway alterations
- Completed a 4-drug induction chemotherapy regimen with intrathecal chemotherapy prior to study entry
- Age between 18 and less than 40 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (Karnofsky score 60% or higher)
- Platelet count above 25,000/uL
- Normal organ function as defined by total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 2.5 times institutional upper limit, and normal creatinine or creatinine clearance ≥ 60 mL/min/1.73 m2
- Agreement to use effective contraception during and prior to study participation
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Receiving any other investigational agent
- Active second malignancy other than non-melanoma skin cancer unless free of disease for 3 or more years
- History of allergic reactions to ruxolitinib or similar agents
- Use of potent CYP3A4 inhibitors or inducers within 5 half-lives before starting study drug
- Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Pregnant or breastfeeding women
- Diagnosis of Down Syndrome
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 3 years
Participants receive ruxolitinib combined with a standard pediatric-based chemotherapy regimen consisting of remission consolidation, interim maintenance, delayed intensification, and maintenance therapy phases.
Multiple visits scheduled throughout treatment phases over 2 to 3 years
Trial Site Locations
Total: 1 location
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Clinical Trials Office
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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