OncoMatch/Clinical Trials/NCT03571321
Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia
Is NCT03571321 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for acute lymphoblastic leukemia.
Treatment: Ruxolitinib · Cyclophosphamide · Cytarabine · Mercaptopurine · Vincristine · Pegaspargase · Rituximab · Methotrexate (Intrathecal Administration) · Methotrexate (Intravenous Administration) · Dexamethasone · Doxorubicin · Thioguanine · Methotrexate Oral Product — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CRLF2 rearrangement
Cytokine receptor-like factor 2 (CRLF2) rearranged (JAK2 mutant or wild-type)
Required: JAK2 fusion
JAK2 ... fusions
Required: EPOR fusion
erythropoietin receptor (EPOR) fusions
Required: SH2B3 deletion
SH2B adaptor protein 3 (SH2B3) deletions
Required: IL7RA mutation
Interleukin-7 receptor subunit alpha (IL7RA) mutations
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: 4-drug induction regimen with intrathecal chemotherapy — induction
patients must have completed a 4-drug induction regimen with intrathecal chemotherapy (modified aBFM regimen or equivalent) as per the institutional standard of care
Cannot have received: any other prior therapy for acute leukemia
Exception: emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; leukapheresis or exchange transfusion to reduce WBC
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).
Lab requirements
Blood counts
Platelet count > 25,000/uL
Kidney function
creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Liver function
total bilirubin ≤ 2 mg/dL; AST/ALT ≤ 2.5 × institutional upper limit of normal
Patients must have normal organ function as defined below: total bilirubin ≤ 2 mg/dL; AST/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. Platelet count > 25,000/uL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Chicago Medical Center · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03571321 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior any other prior therapy for acute leukemia disqualifies patients from enrollment.
Does this trial require CRLF2?
Yes, CRLF2 rearrangement is a required biomarker for enrollment.
Does this trial require JAK2?
Yes, JAK2 fusion is a required biomarker for enrollment.
Does this trial require EPOR?
Yes, EPOR fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 39 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages