Ruxolitinib and Chemotherapy for Ph-like Acute Lymphoblastic Leukemia
This study is looking at whether adding ruxolitinib to standard chemotherapy is safe and tolerable for adolescents and young adults (ages 18-39) with newly diagnosed Ph-like Acute Lymphoblastic Leukemia (ALL). Ph-like ALL is a specific type of blood cancer. You would receive ruxolitinib by mouth, along with a combination of other chemotherapy drugs like cyclophosphamide, cytarabine, mercaptopurine, and vincristine. The main goal is to see how many side effects occur when these treatments are combined. The study plans to enroll 15 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It is not specified if it's randomized or blinded, and the planned enrollment is 15 participants.
- What's involved
- Participants will receive ruxolitinib by mouth, and various chemotherapy drugs (cyclophosphamide, cytarabine, mercaptopurine, vincristine) through IV or by mouth, following different schedules for remission consolidation, interim maintenance, and delayed intensification regimens.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome for side effects will be measured at 24 weeks.
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NCT03571321
Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia
Recruiting
PHASE1Ages 18–39InterventionalTreatmentUniversity of ChicagoInvestigator-initiated
~15 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:RuxolitinibCyclophosphamideCytarabineMercaptopurineVincristinePegaspargase
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 24 weeks
Conditions
Where it's being run
2 sites across 2 statesIllinois1
Texas1
Study leadership
- Wendy Stock, MD · PRINCIPAL_INVESTIGATOR · University of Chicago
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Newly diagnosed de novo B-precursor acute lymphoblastic leukemia (ALL) as determined by World Health Organization (WHO) criteria. Patients must have unequivocal diagnosis of precursor B ALL. This includes an institutional immunophenotyping report that is to assign B-lineage or T-lineage.
"Ph-like" signature, as determined by low density micro-array (LDA) card
Jak-targetable genetic signature as defined by any of the following:
Cytokine receptor-like factor 2 (CRLF2) rearranged (JAK2 mutant or wild-type)
JAK2 or erythropoietin receptor (EPOR) fusions.
Other JAK pathway alterations at the discretion of the principle investigator including, but not limited to:
SH2B adaptor protein 3 (SH2B3) deletions
Interleukin-7 receptor subunit alpha (IL7RA) mutations
Prior therapy
Prior to starting ruxolitinib, patients must have completed a 4-drug induction regimen with intrathecal chemotherapy (modified aBFM regimen or equivalent) as per the institutional standard of care. Recommended induction treatment is outlined in Section 5.1.2.
No additional prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. When indicated, leukapheresis or exchange transfusion is recommended to reduce the white blood cell count (WBC).
Screening may occur at any point prior to or during induction therapy
Age ≥ 18 years and \< 40 years. Because this is specifically a study of the adolescent and young adult population and no adverse event data are currently available on the use of this pediatric-based chemotherapy regimen in patients ≥ 40 years of age, older adults are excluded from this study, but may be eligible for future trials.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥ 60%)
Platelet count \> 25,000/uL.
Patients must have normal organ function as defined below:
total bilirubin ≤ 2 mg/dL
aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 × institutional upper limit of normal
creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
Because the therapeutic agents used in this study are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
Patients who are receiving any other investigational agent.
Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib or other agents used in study.
Use of any potent cytochrome P450 (CYP) 3A4 inhibitor or inducer within 5 half-lives before the first dose of the study drug. Potent inhibitors of CYP3A4 include systemic ketoconazole, posaconazole, voriconazole, clarithromycin, itraconazole, nefazodone, and telithromycin. At the fluconazole dose of 200mg daily used this regimen, there is minimal inhibition of CYP3A4 \[36\] and therefore fluconazole is not prohibited on this trial and no dose modifications should be made in the presence of fluconazole.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because ruxolitinib is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib breastfeeding should be discontinued if the mother is treated with ruxolitinib. These potential risks may also apply to other agents used in this study.
Down Syndrome due to the likelihood of excessive toxicity resulting. These patients should be treated in consultation with a pediatric oncologist.
Burkitt type leukemia
Ph+ ALL at time of diagnosis
What this trial measures
- 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 given24 weeks
Determined by rate of side effects seen when combination is given