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Trial Summary

Principal InvestigatorPradhan, Kamnesh
PhasePhase III
Age GroupChildren
TitleAALL1131, A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum
DescriptionThis randomized phase III trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Be between 1 and 30 years of age
  • Have a White Blood Cell Count of:
    • Age 1-9.99 years: WBC >= 50 000/μL
    • Age 10-30.99 years: Any WBC
  • Have newly diagnosed B lymphoblastic leukemia (2008 WHO classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible
For a full list of participation criteria, please visit
Applicable Disease SitesLeukemia (Child)
Participating InstitutionsIU Health North Hospital
  • IU Health North Hospital
Indiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
  • Riley Hospital for Children
Treatment TypeTreatment
ContactMelissa Lee, Phone: +1 317-944-4281
Pager: 312-1228